Identity
- Trade Name
- Bovie FDA UDI
- Generic Name
- Foetal Doppler system FDA UDI
- Device Name
- ACUDOP II 330, NON-DISPLAY UNIT WITH 2MHZ OB WATERPROOF PROBE FDA UDI
- Model / Reference
- AD-330-A2W FDA UDI
- Description
- ACUDOP II 330, NON-DISPLAY UNIT WITH 2MHZ OB WATERPROOF PROBE FDA UDI
Identifiers
- Catalog Number
- AD-330-A2W FDA UDI
- Primary DI / UDI-DI
- 10607151011502 FDA UDI
- 510(k) Number
- K090465 FDA UDI
- FDA Product Code
- ITX FDA UDILXE FDA UDI
- GMDN Term
- Foetal Doppler system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI884.2660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Foetal Doppler system
The Bovie Foetal Doppler System is a portable, hand-held device designed to noninvasively detect fetal heart beats using ultrasound/Doppler technology. This medical device aids in determining foetal viability and is used in obstetrics and gynecology. The Bovie system features a measuring and display unit, an attached probe, and a handle, allowing for precise measurements of fetal heart rates.
Similar devices
Also classified as Foetal Doppler system.
- CONTEC — Contec Medical Systems Co., Ltd. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Hi-dop — Bistos Co., Ltd. · Class II
- CONTEC — Contec Medical Systems Co., Ltd. · Class II
- VCOMIN Fetal Doppler — Vcomin Technlogy Limited · Class II
- Summit Doppler — CooperSurgical, Inc. · Class II
- DigiDop — Newman Medical · Class II
- MediChoice — CooperSurgical, Inc. · Class II
Cleared under the same submission
K090465 also covers:
- Bovie — BOVIE MEDICAL CORPORATION
- Bovie — BOVIE MEDICAL CORPORATION
- Bovie — BOVIE MEDICAL CORPORATION
- Bovie — BOVIE MEDICAL CORPORATION
- Bovie — BOVIE MEDICAL CORPORATION
- Bovie — BOVIE MEDICAL CORPORATION
- Bovie — BOVIE MEDICAL CORPORATION
- Bovie — BOVIE MEDICAL CORPORATION
- Bovie — BOVIE MEDICAL CORPORATION
- Bovie — BOVIE MEDICAL CORPORATION
- Bovie — BOVIE MEDICAL CORPORATION
- Bovie — BOVIE MEDICAL CORPORATION
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Bovie Medical Corporation
Sources (1)
- FDA UDI 379554d0-36f9-49a9-8c3a-6136f10ecafa 36 fields · synced Jun 29, 2026