Identity
- Trade Name
- ARGUS® PB-1000 FDA UDI
- Generic Name
- Patient monitoring system module, multifunction FDA UDI
- Device Name
- 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
- Model / Reference
- 3.920978 FDA UDI
- 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
- 3.920978 FDA UDI
- Primary DI / UDI-DI
- 07613365000092 FDA UDI
- 510(k) Number
- K012226 FDA UDI
- FDA Product Code
- MHX FDA UDI
- GMDN Term
- Patient monitoring system module, multifunction FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Patient monitoring system module, multifunction
Argus® Pb-1000 by Schiller Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient monitoring system module, multifunction.
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- MPM Module (with MR ECG, NIBP, Temp) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- SOMNOscreen plus PSG+ Tele Camera Compact AASM Set — Somnomedics GmbH
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Cleared under the same submission
K012226 also covers:
- ARGUS® PB-2000 — Schiller Corp.
- Schiller CO2 connecting cable — Schiller Corp.
- Schiller CO2 connecting cable — Schiller Corp.
- Schiller CO2 connecting cable — Schiller Corp.
- Schiller Cardiac output connecting cable — Schiller Corp.
- Schiller Cardiac output connecting cable — Schiller Corp.
- Schiller Cardiac output connecting cable — Schiller Corp.
- Schiller ECG extension wires — Schiller Corp.
- Schiller ECG extension wires — Schiller Corp.
- Schiller ECG patient cable — Schiller Corp.
- Schiller ECG patient cable — Schiller Corp.
- Schiller ECG patient cable — Schiller Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Schiller Corp.
Sources (1)
- FDA UDI 543774c5-0d2e-4796-9bf5-318df376abc2 37 fields · synced Jun 8, 2026