The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Built-in Temperature Monitoring.
| Device ID | K801240 |
| 510k Number | K801240 |
| Device Name: | BUILT-IN TEMPERATURE MONITORING |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | BENTLEY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-27 |
| Decision Date | 1980-06-04 |