The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda Universal Pac.
| Device ID | K901117 |
| 510k Number | K901117 |
| Device Name: | OHMEDA UNIVERSAL PAC |
| Classification | Gas-machine, Anesthesia |
| Applicant | OHMEDA MEDICAL OHMEDA DRIVE, P.O. BOX 7550 Madison, WI 53707 -7550 |
| Contact | Timothy M Davis |
| Correspondent | Timothy M Davis 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 | 1990-03-08 |
| Decision Date | 1990-09-07 |