Identity
- Trade Name
- BF8M15S8A FDA UDI
- Generic Name
- Noninvasive vascular ultrasound system probe FDA UDI
- Device Name
- 8 MHz flat clinic CW Doppler probe. FDA UDI
- Model / Reference
- BF8M15S8A FDA UDI
- Description
- 8 MHz flat clinic CW Doppler probe. FDA UDI
Identifiers
- Catalog Number
- BF8M15S8A FDA UDI
- Primary DI / UDI-DI
- 00894912002296 FDA UDI
- 510(k) Number
- K934638 FDA UDI
- FDA Product Code
- JOP FDA UDI
- GMDN Term
- Noninvasive vascular ultrasound system probe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2880 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 probe
Bf8m15s8a by Koven Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K934638 also covers:
- BF2M20S8A — Koven Technology, Inc.
- BT10M5S8A — Koven Technology, Inc.
- BT10M5S8C — Koven Technology, Inc.
- BT5M05S8A — Koven Technology, Inc.
- BT5M05S8C — Koven Technology, Inc.
- BT8M05S8A — Koven Technology, Inc.
- BT8M05S8C — Koven Technology, Inc.
- LRP-08 — Koven Technology, Inc.
- Pencil probe — Koven Technology, Inc.
- Pencil probe — Koven Technology, Inc.
- Pencil probe — Koven Technology, Inc.
- Pencil 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 10fbb03c-5c65-4094-976b-a929ca9cffe9 35 fields · synced Jun 9, 2026