Identity
- Trade Name
- ADVANCED FETAL MONITOR FDA UDI
- Generic Name
- Foetal cardiac monitor FDA UDI
- Model / Reference
- FM-9000 PLUS D FDA UDI
Identifiers
- Primary DI / UDI-DI
- B510FM9000PLUSD1 FDA UDI
- 510(k) Number
- K112317 FDA UDI
- FDA Product Code
- HGM FDA UDI
- GMDN Term
- Foetal cardiac monitor 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
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: Foetal cardiac monitor
Advanced Fetal Monitor by Advanced Instrumentations, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Foetal cardiac monitor.
- Compact FM — Avante · Class II
- Fetal Monitor — Edan Instruments, Inc. · Class II
- FC700 — Bionet Company, Ltd. · Class II
- Fetal monitor — Edan Instruments, Inc. · Class II
- Compact Plus — Avante · Class II
- Compact Plus — Avante · Class II
- Compact Plus — Avante · Class II
- Fetal & maternal monitor — Edan Instruments, Inc. · Class II
Cleared under the same submission
K112317 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 b1adcdc6-679c-4563-b918-7571cdba5c44 34 fields · synced May 30, 2026