The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns 7000 Monitor Module.
Device ID | K801097 |
510k Number | K801097 |
Device Name: | SARNS 7000 MONITOR MODULE |
Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
Applicant | 3M HEALTH CARE, SARNS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DTQ |
CFR Regulation Number | 870.4220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-05-09 |
Decision Date | 1980-05-20 |