The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns 9000 Heart-lung Console.
Device ID | K871131 |
510k Number | K871131 |
Device Name: | SARNS 9000 HEART-LUNG CONSOLE |
Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
Applicant | 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
Contact | Joseph W O'donnell |
Correspondent | Joseph W O'donnell 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
Product Code | DTQ |
CFR Regulation Number | 870.4220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-20 |
Decision Date | 1987-05-21 |