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 |