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PB-3000 Var. 7, sub-variant: C (main device 3.921008)
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 1A.701307Model ARGUS PB-3000
by Schiller Ag
Identity
- Trade Name
- PB-3000 Var. 7, sub-variant: C (main device 3.921008) EUDAMEDARGUS PB-3000 FDA UDI
- Generic Name
- Patient monitoring system module, multifunction FDA UDI
- Device Name
- The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a medical device or a medical System (Host System) for acquiring, analysing, and transmission of patient vitals and other pertinent clinical data. FDA UDI
- Model / Reference
- ARGUS PB-3000 EUDAMED1A.701307 EUDAMEDPB-3000 Var.7, sub-variant: C FDA UDI
- Description
- The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a medical device or a medical System (Host System) for acquiring, analysing, and transmission of patient vitals and other pertinent clinical data. FDA UDI
Identifiers
- Catalog Number
- 1A.701307 FDA UDI
- Primary DI / UDI-DI
- 07613365003024 EUDAMEDFDA UDI
- Basic UDI-DI
- 76133650000000014U EUDAMED
- Direct Marketing DI
- 07613365003024 EUDAMED
- 510(k) Number
- K221056 FDA UDI
- FDA Product Code
- MHX 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 UDI
- Regulation Number
- 870.1025 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
PB-3000 Var. 7, sub-variant: C (main device 3.921008) by Schiller AG — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221056 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 76133650000000014U | Class IIb | Active |
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Manufacturer
- Manufacturer
- Schiller Ag
- EUDAMED SRN
- CH-MF-000012722
- Authorised Representative
- SCHILLER Medizintechnik GmbH DE-AR-000006934
Sources (3)
- EUDAMED 1a7363f9-3944-4301-a8af-d00cc67f7b63 61 fields · synced Jul 10, 2026
- FDA UDI 02c619f8-fe76-448c-80bd-2b2fd6fe5e5f 37 fields · synced May 30, 2026
- FDA 510(k) K221056 1 fields · synced May 18, 2026