HANDHELD DOPLER/PEN TRANSDUCER 3MHZ
FDA 510(k) clearance K854590 · decided 1986-04-23
Clearance details
- K-number
- K854590
- Device name
- HANDHELD DOPLER/PEN TRANSDUCER 3MHZ
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-11-18
- Decision date
- 1986-04-23
- Days to decision
- 156 days
- Clearance type
- Traditional
- Product code
- JAF
- Device class
- 2
- Regulation number
- 892.1540
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Santa Ana, CA, 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 |
|---|---|---|
| Laminar P1 (LDH-HW-001) (K242487) | Laminar Digital Health, Inc. | 2024-12-13 |
| THD REVOLUTION (K141657) | Thd Spa | 2015-02-24 |
| SIMPLEABI (K110628) | Newman Medical | 2011-05-12 |
| LIFEDOP MODEL 300ABI (K093393) | Summit Doppler Systems, Inc. | 2009-12-24 |
| THD SLIDE ONE (K090009) | Thd Spa | 2009-01-28 |
| THD SLIDE (K081429) | Thd Spa | 2008-07-30 |
| THD (K070815) | G.F. S.R.L. | 2007-06-20 |
| VISTA AVS (K063600) | Summit Doppler Systems, Inc. | 2006-12-19 |
| STETHOFLUX (K060064) | Odvi | 2006-04-10 |
| DOPPLER GUIDED PROCTOSCOPE, MODEL 500H (K052067) | Multigon Industries, Inc. | 2005-08-29 |
| NICOLET VERSALAB (K010521) | Nicolet Biomedical | 2001-03-09 |
| CAREDOP II (K982635) | Nicolet Biomedical | 1998-08-07 |
Recalls involving this device
No recalls on record reference this clearance.