The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda Apac (advanced Portable Anesthesia Care) System.
| Device ID | K965041 |
| 510k Number | K965041 |
| Device Name: | OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM |
| Classification | Gas-machine, Anesthesia |
| Applicant | OHMEDA MEDICAL OHMEDA DRIVE, P.O. BOX 7550 Madison, WI 53707 -7550 |
| Contact | Charles Morreale |
| Correspondent | Charles Morreale 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 | 1996-12-17 |
| Decision Date | 1997-06-17 |
| Summary: | summary |