Identity
- Trade Name
- DigiDop FDA UDI
- Generic Name
- Foetal Doppler system FDA UDI
- Device Name
- DD-II 330 Non-Display Doppler (main unit only) FDA UDI
- Model / Reference
- DD-330 FDA UDI
- Description
- DD-II 330 Non-Display Doppler (main unit only) FDA UDI
Identifiers
- Catalog Number
- DD-330 FDA UDI
- Primary DI / UDI-DI
- 00852785008906 FDA UDI
- 510(k) Number
- K090465 FDA UDI
- FDA Product Code
- LXE FDA UDIJAF FDA UDI
- GMDN Term
- Foetal Doppler system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.2660 FDA UDI892.1540 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: Foetal Doppler systemNoninvasive vascular ultrasound system
DigiDop by Newman Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Noninvasive vascular ultrasound system.
- Summit Doppler — CooperSurgical, Inc. · Class II
- Summit Doppler — CooperSurgical, Inc. · Class II
- NovaGuide™ Intelligent Ultrasound System — Novasignal Corporation · Class II
- Vave — VAVE HEALTH INC · Class II
- TRIA II Display Doppler — CooperSurgical, Inc. · Class II
- Summit Doppler — CooperSurgical, Inc. · Class II
- A.M.I. HAL Handle — AMI Agency for Medical Innovations GmbH · Class II
- SMARTNEEDLE — TELEFLEX INCORPORATED · 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
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
- Newman Medical
Sources (1)
- FDA UDI f4b0d48e-269f-4f6d-b5e9-8b26482aa3e4 37 fields · synced May 30, 2026