The following data is part of a premarket notification filed by American Bentley with the FDA for Umbilical Artery Oxygen Probe Model Uap-100.
Device ID | K872896 |
510k Number | K872896 |
Device Name: | UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-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 | 1987-07-23 |
Decision Date | 1988-02-12 |