Bovie

FDA UDI

Class II (US FDA UDI)

by Bovie Medical Corporation

Identity

Trade Name: Bovie FDA UDI
Generic Name: Foetal Doppler system FDA UDI
Device Name: ACUDOP II 330, NON-DISPLAY UNIT WITH 2MHZ OB PROBE FDA UDI
Model / Reference: AD-330-A2 FDA UDI
Description: ACUDOP II 330, NON-DISPLAY UNIT WITH 2MHZ OB PROBE FDA UDI

Identifiers

Catalog Number: AD-330-A2 FDA UDI
Primary DI / UDI-DI: 10607151011496 FDA UDI
510(k) Number: K090465 FDA UDI
FDA Product Code: LXE FDA UDI
ITX FDA UDI
GMDN Term: Foetal Doppler system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.2660 FDA UDI
892.1570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Foetal Doppler system

Bovie by Bovie Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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:

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: Bovie Medical Corporation

Sources (1)

FDA UDI a9691d38-4f78-4269-b831-520b72f0fd9e 36 fields · synced Jun 1, 2026