The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns Temp. Control And Monitor System (tcm Ii).
Device ID | K883603 |
510k Number | K883603 |
Device Name: | SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II) |
Classification | Controller, Temperature, Cardiopulmonary Bypass |
Applicant | 3M HEALTH CARE, SARNS 6200 JACKSON RD. Ann Arbor, MI 48103 |
Contact | D Shimokochi |
Correspondent | D Shimokochi 3M HEALTH CARE, SARNS 6200 JACKSON RD. Ann Arbor, MI 48103 |
Product Code | DWC |
CFR Regulation Number | 870.4250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-23 |
Decision Date | 1988-11-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00886799001769 | K883603 | 000 |
00886799001752 | K883603 | 000 |
00886799001745 | K883603 | 000 |
00886799000168 | K883603 | 000 |
00886799000151 | K883603 | 000 |
00886799000014 | K883603 | 000 |