KRK — Manometer, Blood-Pressure, Venous Class II
FDA product code KRK covers "Manometer, Blood-Pressure, Venous", a Class II medical device regulated under 21 CFR 870.1140. Submissions are reviewed by the Cardiovascular panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KRK
- Device Class
- Class II
- Regulation Number
- 870.1140
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K950607 | aloka co | UST-5268P-5 TRANSDUCER | September 15, 1995 |
| K904674 | medex | CENTRAL VENOUS PRESSURE MANOMETER | December 27, 1990 |
| K884386 | ethitek pharmaceuticals | ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK | January 5, 1989 |
| K875322 | schneider-shilley (usa) | MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER | March 28, 1988 |
| K861605 | shiley | SCHNEIDER-SHILEY PRESSURE MANOMETER | May 28, 1986 |
| K830910 | exco | MANOMETER SET C.V.P. #S 298/299 | April 5, 1983 |
| K813498 | burron medical products | MEDIFIX | January 7, 1982 |
| K813195 | burron medical products | MEDIFIX GRADUATED SCALE | December 29, 1981 |
| K790668 | deco medical | VENOUS PRESSURE MONITOR, MF 35 LF | May 23, 1979 |