Identity
- Trade Name
- ADVANCED PATIENT MONITOR FDA UDI
- Generic Name
- Patient monitoring system module, multifunction FDA UDI
- Model / Reference
- PM-2000TM FDA UDI
Identifiers
- Primary DI / UDI-DI
- B510PM2000TM1 FDA UDI
- 510(k) Number
- K132077 FDA UDI
- FDA Product Code
- CBQ FDA UDIFLL FDA UDIDRT FDA UDICCL FDA UDIDSI FDA UDIMHX FDA UDIDXN FDA UDIDQA FDA UDICBR FDA UDIMLD FDA UDICBS FDA UDICCK FDA UDIDSK FDA UDIDSA FDA UDI
- GMDN Term
- Patient monitoring system module, multifunction FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1500 FDA UDI880.2910 FDA UDI870.2300 FDA UDI868.1720 FDA UDI870.1025 FDA UDI870.1130 FDA UDI870.2700 FDA UDI868.1700 FDA UDI868.1620 FDA UDI868.1400 FDA UDI870.1110 FDA UDI870.2900 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
No
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
Category: Patient monitoring system module, multifunction
Advanced Patient Monitor by Advanced Instrumentations, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K132077 also covers:
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
- Advanced Instrumentations, Inc.
Sources (1)
- FDA UDI 37a65139-3f56-49f8-b1a7-350662845ab7 34 fields · synced Jun 8, 2026