The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda 7800 Anesthesia Ventilator Software Update.
| Device ID | K902084 |
| 510k Number | K902084 |
| Device Name: | OHMEDA 7800 ANESTHESIA VENTILATOR SOFTWARE UPDATE |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | OHMEDA MEDICAL OHMEDA DRIVE, P.O. BOX 7550 Madison, WI 53707 -7550 |
| Contact | M Davis |
| Correspondent | M Davis OHMEDA MEDICAL OHMEDA DRIVE, P.O. BOX 7550 Madison, WI 53707 -7550 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-08 |
| Decision Date | 1990-10-01 |