The following data is part of a premarket notification filed by American Bentley with the FDA for Oxygen Monitor No. Om-100, Oxygen Probe No. Op-100.
| Device ID | K860106 |
| 510k Number | K860106 |
| Device Name: | OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100 |
| Classification | Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling |
| Applicant | AMERICAN BENTLEY P.O. BOX 19522 Irvine, CA 92713 |
| Contact | Donald A Raible |
| Correspondent | Donald A Raible AMERICAN BENTLEY P.O. BOX 19522 Irvine, CA 92713 |
| Product Code | CCE |
| CFR Regulation Number | 868.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-13 |
| Decision Date | 1986-02-26 |