The following data is part of a premarket notification filed by Deco Medical, Inc. with the FDA for Venous Pressure Monitor, Mf 35 Lf.
Device ID | K790668 |
510k Number | K790668 |
Device Name: | VENOUS PRESSURE MONITOR, MF 35 LF |
Classification | Manometer, Blood-pressure, Venous |
Applicant | DECO MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KRK |
CFR Regulation Number | 870.1140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-06 |
Decision Date | 1979-05-23 |