Hd-307 HD307--8
Hd-307 HD307--8 (HD-307-8) is a Class II device made by Koven Technology, Inc., cleared under FDA 510(k) K912409 on 23 Dec 1991 and listed in FDA GUDID since 24 Feb 2016 (UDI-DI 00894912002104), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00894912002104 | Date24 Feb 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK912409 | Date23 Dec 1991 | StatusActive |
Official records
- AccessGUDID record 00894912002104
- FDA 510(k) database K912409
Across registries
- FDA 510(k) K912409 decided 23 Dec 1991 Active
- FDA GUDID UDI-DI 00894912002104 listed 24 Feb 2016 Listed
Timeline
- Cleared FDA 510(k) K912409
- Listed FDA GUDID 00894912002104
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Hd-307
- Generic name
- Vascular ultrasound system control unit
- Model / Ref / Catalog
- HD307--8, HD-307-8
- Primary DI / UDI-DI
- 00894912002104
- 510(k) Number
- FDA product code
- JOP
- GMDN term
- Vascular ultrasound system control unit
- Device class
- Class II
- Regulation number
- 870.2880
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code JOP (Transducer, Ultrasonic).
- SCANHEADS ACCESS 10 10PV B10 by Advanced Technology Laboratories, Inc.
- MOD 482 by Hoffrel Instruments, Inc.
- SPECTRADOP by Bennett and Assoc., Inc.
- TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASO by Hewlett-Packard Co.
- MODEL HD-207 BIDIRECTIONAL VELOCITY METER by Koven and Assoc., Inc.
- MODIFIED RADIUS - MODEL NUMBER MM 5000 by Ultrasonix, Inc.
- VF-PD-120 by Valpey-Fisher Corp.
- VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING by Us Vascular, LLC
- ULTRASOUND TRANSDUCER #21230A 7.5MHZ SHORT FOCUS by Hewlett-Packard Co.
- ACUSON L538 TRANSDUCER by Acuson Computed Sonography