Identity
- Trade Name
- HP Probe FDA UDI
- Generic Name
- Invasive vascular ultrasound system probe FDA UDI
- Device Name
- PW Bayonet style flexible tip Doppler probe, 10 MHz FDA UDI
- Model / Reference
- HP10M2N5AF FDA UDI
- Description
- PW Bayonet style flexible tip Doppler probe, 10 MHz FDA UDI
Identifiers
- Catalog Number
- HP10M2N5AF FDA UDI
- Primary DI / UDI-DI
- 00894912002654 FDA UDI
- 510(k) Number
- K935994 FDA UDI
- FDA Product Code
- JAF FDA UDIITX FDA UDI
- GMDN Term
- Invasive vascular ultrasound system probe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1540 FDA UDI892.1570 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
Hydrogen Peroxide FDA UDI
Category: Invasive vascular ultrasound system probe
HP Probe by Koven Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Invasive vascular ultrasound system probe.
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- Adapter cable 16 MHz probe, 1mm — Compumedics Germany GmbH · Class II
Cleared under the same submission
K935994 also covers:
- ACP-08 — Koven Technology, Inc.
- CRP Probe — Koven Technology, Inc.
- CRP Probe — Koven Technology, Inc.
- CRP Probe — Koven Technology, Inc.
- FDP Probe — Koven Technology, Inc.
- HP Probe — Koven Technology, Inc.
- NP Probe — Koven Technology, Inc.
- NP Probe — Koven Technology, Inc.
- NP Probe — Koven Technology, Inc.
- NP Probe — Koven Technology, Inc.
- NRP Probe — Koven Technology, Inc.
- NRP 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 5fcd32e1-b77d-4da1-a389-764b69be02a1 36 fields · synced Jun 9, 2026