MEDIFIX
FDA 510(k) clearance K813498 · decided 1982-01-07
Clearance details
- K-number
- K813498
- Device name
- MEDIFIX
- Applicant
- Burron Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-12-14
- Decision date
- 1982-01-07
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- KRK
- Device class
- 2
- Regulation number
- 870.1140
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Walker, MI, 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 |
|---|---|---|
| UST-5268P-5 TRANSDUCER (K950607) | Aloka Co., Ltd. | 1995-09-15 |
| CENTRAL VENOUS PRESSURE MANOMETER (K904674) | Medex, Inc. | 1990-12-27 |
| ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK (K884386) | Ethitek Pharmaceuticals Co. | 1989-01-05 |
| MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER (K875322) | Schneider-Shilley (Usa) | 1988-03-28 |
| SCHNEIDER-SHILEY PRESSURE MANOMETER (K861605) | Shiley, Inc. | 1986-05-28 |
| MANOMETER SET C.V.P. #S 298/299 (K830910) | Exco, Inc. | 1983-04-05 |
| MEDIFIX GRADUATED SCALE (K813195) | Burron Medical Products, Inc. | 1981-12-29 |
| VENOUS PRESSURE MONITOR, MF 35 LF (K790668) | Deco Medical, Inc. | 1979-05-23 |
Recalls involving this device
No recalls on record reference this clearance.