The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Oxygen Consumption Monitor #ocm-0100.
| Device ID | K823359 |
| 510k Number | K823359 |
| Device Name: | OXYGEN CONSUMPTION MONITOR #OCM-0100 |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | BENTLEY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-05 |
| Decision Date | 1983-01-05 |