The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Integrated Membrane Oxygenator W/cardiotomy Filter.
| Device ID | K874841 |
| 510k Number | K874841 |
| Device Name: | INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | BENTLEY LABORATORIES, INC. 17502 ARMSTRONG AVE. P.O. BOX 19522 Irvine, CA 92713 -9522 |
| Contact | Merritt Girgis |
| Correspondent | Merritt Girgis BENTLEY LABORATORIES, INC. 17502 ARMSTRONG AVE. P.O. BOX 19522 Irvine, CA 92713 -9522 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-24 |
| Decision Date | 1988-02-02 |