The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Datex-ohmeda 7900 Ventilator Enhancements.
| Device ID | K023366 |
| 510k Number | K023366 |
| Device Name: | DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | DATEX-OHMEDA, INC. P.O. BOX 7550 Madison, WI 53707 |
| Contact | Michael A Chilbert |
| Correspondent | Michael A Chilbert DATEX-OHMEDA, INC. P.O. BOX 7550 Madison, WI 53707 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-08 |
| Decision Date | 2003-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682102360 | K023366 | 000 |
| 00840682102353 | K023366 | 000 |
| 00840682102308 | K023366 | 000 |