The following data is part of a premarket notification filed by Life Support, Inc. with the FDA for Uc-2000 Uterine Catherization System.
Device ID | K791633 |
510k Number | K791633 |
Device Name: | UC-2000 UTERINE CATHERIZATION SYSTEM |
Classification | Recorder, Pressure, Intrauterine |
Applicant | LIFE SUPPORT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HFO |
CFR Regulation Number | 884.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-21 |
Decision Date | 1979-09-17 |