DOPLETTE 10
FDA 510(k) clearance K851269 · decided 1985-07-29
Clearance details
- K-number
- K851269
- Device name
- DOPLETTE 10
- Applicant
- Imex Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-01-23
- Decision date
- 1985-07-29
- Days to decision
- 187 days
- Clearance type
- Traditional
- Product code
- JOP
- Device class
- 2
- Regulation number
- 870.2880
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Golden, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Falcon/Xpress (Falcon/Xpress) (K242662) | Viasonix , Ltd. | 2024-12-18 |
| VasoGuard (V10, V8, V6, V4, V2) (K233976) | Corvascular Diagnostics, LLC | 2024-07-19 |
| Smartdop XT6 (K153762) | Koven Technology, Inc. | 2016-05-25 |
| SMARTDOP XT (K131623) | Koven Technology, Inc. | 2014-01-17 |
| VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING (K131860) | Us Vascular, LLC | 2013-09-27 |
| FALCON (K111416) | Viasonix , Ltd. | 2011-07-15 |
| STUDIODOP VICORDER (K071730) | Skidmore Medical, Limited | 2007-12-20 |
| ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1 (K010482) | Echocath, Inc. | 2001-03-20 |
| NICOLET VASOGUARD (K002766) | Nicolet Biomedical | 2000-11-30 |
| ECHOFLOW DOPPLER BLOOD VELOCITY METER (K990642) | Echocath, Inc. | 1999-09-16 |
| SPECTRADOP (K925078) | Bennett and Assoc., Inc. | 1995-07-17 |
| REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8 (K934638) | Koven Technology, Inc. | 1994-05-13 |
Recalls involving this device
No recalls on record reference this clearance.