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 |