Identity
- Trade Name
- OptoMonitor 3 FDA UDI
- Generic Name
- Cardiac catheterization laboratory computer FDA UDI
- Model / Reference
- Pressure output cable - Philips XperFCII FDA UDI
Identifiers
- Catalog Number
- F201217 FDA UDI
- Primary DI / UDI-DI
- 07540184012176 FDA UDI
- 510(k) Number
- K202943 FDA UDI
- FDA Product Code
- DXO FDA UDI
- GMDN Term
- Cardiac catheterization laboratory computer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2870 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiac catheterization laboratory computer
OptoMonitor 3 by Opsens — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K202943 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Opsens
Sources (1)
- FDA UDI 2b199dfd-7190-4ea0-97ff-75c23f788b8a 35 fields · synced May 30, 2026