The following data is part of a premarket notification filed by Airoflex Medical, Inc. with the FDA for Babyflex Patient Circuit.
| Device ID | K874559 |
| 510k Number | K874559 |
| Device Name: | BABYFLEX PATIENT CIRCUIT |
| Classification | Set, Tubing And Support, Ventilator (w Harness) |
| Applicant | AIROFLEX MEDICAL, INC. ATTORNEY AT LAW 2085 RUSTIN AVENUE Riverside, CA 92507 |
| Contact | Stanley E Fry |
| Correspondent | Stanley E Fry AIROFLEX MEDICAL, INC. ATTORNEY AT LAW 2085 RUSTIN AVENUE Riverside, CA 92507 |
| Product Code | BZO |
| CFR Regulation Number | 868.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-04 |
| Decision Date | 1987-12-21 |