Identity
- Trade Name
- BiDop 7 FDA UDI
- Generic Name
- Noninvasive vascular ultrasound system FDA UDI
- Device Name
- Hand held Doppler FDA UDI
- Model / Reference
- BiDop 7 FDA UDI
- Description
- Hand held Doppler FDA UDI
Identifiers
- Catalog Number
- BiDop 7 FDA UDI
- Primary DI / UDI-DI
- 00894912002159 FDA UDI
- 510(k) Number
- K201114 FDA UDI
- FDA Product Code
- DPW FDA UDI
- GMDN Term
- Noninvasive vascular ultrasound system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2100 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: Noninvasive vascular ultrasound system
BiDop 7 by Koven Technology, Inc. — 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
- DigiDop — Newman Medical · 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
- DigiDop — Newman Medical · Class II
Cleared under the same submission
K201114 also covers:
- BiDop 7 probe — Koven Technology, Inc.
- BiDop 7 probe — Koven Technology, Inc.
- BiDop 7 probe — Koven Technology, Inc.
- BiDop 7 probe — Koven Technology, Inc.
- BiDop 7 probe — Koven Technology, Inc.
- BiDop 7 probe — Koven Technology, Inc.
- BiDop 7 probe — Koven Technology, Inc.
- BiDop 7 probe — Koven Technology, Inc.
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
- Koven Technology, Inc.
Sources (1)
- FDA UDI 2dda8d57-daa2-4019-a1e9-56b9ec5d2f6b 36 fields · synced Jun 9, 2026