The following data is part of a premarket notification filed by American Bentley with the FDA for Oxygen Monitor Om-100 & Oxygen Probe Op-100.
| Device ID | K853786 |
| 510k Number | K853786 |
| Device Name: | OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100 |
| Classification | Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling |
| Applicant | AMERICAN BENTLEY 17502 ARMSTRONG AVE. Irvine, CA 92714 |
| Contact | Donald A Raible |
| Correspondent | Donald A Raible AMERICAN BENTLEY 17502 ARMSTRONG AVE. Irvine, CA 92714 |
| Product Code | CCE |
| CFR Regulation Number | 868.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-10 |
| Decision Date | 1985-10-16 |