Argus PB-1000 Monitoring System
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Schiller AG
Identity
- Trade Name
- ARGUS PB-1000 EUDAMEDARGUS® PB-1000 FDA UDI
- Generic Name
- Patient monitoring system module, multifunction FDA UDI
- Device Name
- ARGUS PB-1000 EUDAMEDThe ARGUS® PB-1000 parameter box is acquiring and monitoring patients vital parameters such as ECG, invasive blood pressure (IBP), temperature, non-invasive blood pressure (NIPB), CO2, SpO2 and Cardiac Output. All vital parameters and evaluations are registered and calculated in the ARGUS® PB-1000. This data is then transmitted to the visualization unit via a serial interface. FDA UDI
- Model / Reference
- 3.920948 EUDAMEDFDA UDIPB-1000 - Base device LP/30 Merge EUDAMEDPB-1000 - Base device LP/30 SAG EUDAMED3.920977 EUDAMED
- Description
- The ARGUS® PB-1000 parameter box is acquiring and monitoring patients vital parameters such as ECG, invasive blood pressure (IBP), temperature, non-invasive blood pressure (NIPB), CO2, SpO2 and Cardiac Output. All vital parameters and evaluations are registered and calculated in the ARGUS® PB-1000. This data is then transmitted to the visualization unit via a serial interface. FDA UDI
Identifiers
- Catalog Number
- 3.920948 FDA UDI
- Primary DI / UDI-DI
- 07613365000085 EUDAMEDFDA UDI07613365001655 EUDAMED
- Basic UDI-DI
- B-07613365000085 EUDAMEDB-07613365001655 EUDAMED
- 510(k) Number
- FDA Product Code
- MHX FDA 510(k)FDA UDI
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
- GMDN Term
- Patient monitoring system module, multifunction FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.1025 FDA 510(k)
- Regulation Number
- 870.1025 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Argus PB-1000 Monitoring System is a physiological patient monitor designed for arrhythmia detection and alarm functionality. Classified as a Physiological Monitor under the FDA’s nomenclature, it continuously assesses cardiac activity to identify abnormal rhythms and trigger alerts for clinical intervention.
This device is intended for use in clinical settings, including hospitals and cardiac care units, where real-time cardiac monitoring is required. Supplied as a reusable system, it adheres to FDA 510K and MDD regulatory standards. The system operates within Class II risk classification and is not MRI-compatible. Storage and maintenance follow manufacturer guidelines to ensure proper functionality and sterility.
Frequently asked questions
What is the primary purpose of the Argus PB-1000 Monitoring System and where is it typically used?
The Argus PB-1000 Monitoring System is designed specifically for continuous arrhythmia detection and alarm functionality, allowing clinicians to monitor cardiac activity in real-time. It is intended for use in clinical settings such as hospitals and cardiac care units, where ongoing assessment of heart rhythms is critical for patient safety and timely intervention.
Is the Argus PB-1000 a single-use or reusable device, and how should it be maintained?
The Argus PB-1000 is supplied as a reusable system, meaning it is intended for repeated use across multiple patients. Proper storage and maintenance must follow the manufacturer’s guidelines to ensure functionality and sterility, as outlined in Schiller AG’s instructions.
What regulatory pathways has the Argus PB-1000 followed, and what does that mean for its use?
The Argus PB-1000 has been authorized through the FDA 510K pathway (substantially equivalent under K012226) and complies with the MDD (Medical Device Directive). This means it has undergone regulatory review to demonstrate safety and performance for its intended use as a physiological patient monitor with arrhythmia detection, ensuring it meets established standards for clinical deployment.
Can the Argus PB-1000 be used in an MRI environment, and why?
No, the Argus PB-1000 is not MRI-compatible. This is explicitly stated in the device description, meaning it should not be used in proximity to MRI machines, as electromagnetic interference or safety risks could arise.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Monitoring – Wikipedia, Monitoring - Einfach & verständlich erklärt - Mit Definition, Monitoring | Bedeutung & Erklärung | Legal Wiki, Service-Monitoring – Wikipedia
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K012226 | Class II | Active |
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Manufacturer
- Manufacturer
- Schiller AG
Sources (4)
- FDA 510(k) K012226 24 fields · synced Sep 18, 2026
- FDA UDI 71f0d269-eaad-49d9-a71c-8a250353bd79 37 fields · synced May 30, 2026
- EUDAMED 6cf66876-743c-42fb-82a0-7da994a0105a 61 fields · synced Jul 9, 2026
- EUDAMED e287c541-eb8d-4e96-9fe5-8f7bf305184c 61 fields · synced Jul 13, 2026