The following data is part of a premarket notification filed by American Bentley with the FDA for Indwelling Blood Carbondioxide Partial Pres. Analy.
| Device ID | K870911 |
| 510k Number | K870911 |
| Device Name: | INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY |
| Classification | Analyzer, Gas, Carbon-dioxide, 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 | CCC |
| CFR Regulation Number | 868.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-06 |
| Decision Date | 1987-05-29 |