The following data is part of a premarket notification filed by Sams, Inc. with the FDA for Temperature Control & Monitor.
| Device ID | K841402 |
| 510k Number | K841402 |
| Device Name: | TEMPERATURE CONTROL & MONITOR |
| Classification | Controller, Temperature, Cardiopulmonary Bypass |
| Applicant | SAMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DWC |
| CFR Regulation Number | 870.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-03 |
| Decision Date | 1984-06-11 |