Identity
- Trade Name
- seca mVSA 535 FDA UDI
- Generic Name
- Multiple physiological parameter spot-check system, clinical FDA UDI
- Device Name
- Spot-check-monitor inclusive blood pressure, Masimo Spo2 and FILAC temperature module. FDA UDI
- Model / Reference
- 535 FDA UDI
- Description
- Spot-check-monitor inclusive blood pressure, Masimo Spo2 and FILAC temperature module. FDA UDI
Identifiers
- Catalog Number
- 5351220131 FDA UDI
- Primary DI / UDI-DI
- 04012030019545 FDA UDI
- 510(k) Number
- K192092 FDA UDI
- FDA Product Code
- DXN FDA UDIDQA FDA UDIFLL FDA UDI
- GMDN Term
- Multiple physiological parameter spot-check system, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 FDA UDI870.2700 FDA UDI880.2910 FDA UDI
- Commercial Distribution
- Not 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
seca mVSA 535 by Seca Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K192092 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
- Seca Corp.
Sources (1)
- FDA UDI de237bca-af9e-43a3-ab93-7a665075931b 37 fields · synced May 30, 2026