510(k) K813195
- Device
- MEDIFIX GRADUATED SCALE
- Applicant
- BURRON MEDICAL PRODUCTS, INC.
- 510(k) number
- K813195
- Product code
- KRK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-12-29
- Date received
- 1981-11-12
- Regulation
- 870.1140
- Classification name
- Manometer, Blood-pressure, Venous
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3012307300
- 9616567
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KRK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K950607 | UST-5268P-5 TRANSDUCER | Aloka Co., Ltd. | 1995-09-15 |
| K904674 | CENTRAL VENOUS PRESSURE MANOMETER | Medex, Inc. | 1990-12-27 |
| K884386 | ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK | Ethitek Pharmaceuticals Co. | 1989-01-05 |
| K875322 | MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER | Schneider-Shilley (Usa) | 1988-03-28 |
| K861605 | SCHNEIDER-SHILEY PRESSURE MANOMETER | Shiley, Inc. | 1986-05-28 |
| K830910 | MANOMETER SET C.V.P. #S 298/299 | Exco, Inc. | 1983-04-05 |
| K813498 | MEDIFIX | Burron Medical Products, Inc. | 1982-01-07 |
| K790668 | VENOUS PRESSURE MONITOR, MF 35 LF | Deco Medical, Inc. | 1979-05-23 |
Legacy Summary#
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FDA Review#
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