The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda Autoclavable Bellows Assembly.
| Device ID | K921742 |
| 510k Number | K921742 |
| Device Name: | OHMEDA AUTOCLAVABLE BELLOWS ASSEMBLY |
| Classification | Gas-machine, Anesthesia |
| Applicant | OHMEDA MEDICAL OHMEDA DRIVE, P.O. BOX 7550 Madison, WI 53707 -7550 |
| Contact | Graham Lukey |
| Correspondent | Graham Lukey OHMEDA MEDICAL OHMEDA DRIVE, P.O. BOX 7550 Madison, WI 53707 -7550 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-13 |
| Decision Date | 1993-05-26 |