Identity
- Trade Name
- FetaLink+ FDA UDI
- Generic Name
- Obstetrical monitoring/analysis software FDA UDI
- Model / Reference
- FL+Android1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850017753136 FDA UDI
- 510(k) Number
- K121758 FDA UDI
- FDA Product Code
- HGM FDA UDI
- GMDN Term
- Obstetrical monitoring/analysis software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.2740 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
No
FDA UDI
Category: Obstetrical monitoring/analysis software
FetaLink+ by Cerner Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Obstetrical monitoring/analysis software.
- PeriCALM® Curve™ — PERIGEN SOLUTIONS LTD · Class II
- PeriWatch™ HUB™ — PERIGEN SOLUTIONS LTD · Class II
- PeriWatch™ Curve™ — PERIGEN SOLUTIONS LTD · Class II
- PeriWatch™ Vigilance™ — PERIGEN SOLUTIONS LTD · Class II
- PeriWatch™ HUB™ — PERIGEN SOLUTIONS LTD · Class II
- PeriWatch Vigilance® HUB™ — PERIGEN SOLUTIONS LTD · Class II
- PeriCALM® Tracings™, HUB Module — PERIGEN SOLUTIONS LTD · Class II
- PeriWatch Vigilance® Cues™ — PERIGEN SOLUTIONS LTD · Class II
Cleared under the same submission
K121758 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
- Cerner Corporation
Sources (1)
- FDA UDI 24fede04-3f01-40e5-8c64-4e722ddd3986 33 fields · synced May 30, 2026