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 |