The following data is part of a premarket notification filed by Cardinal Health 207, Inc. with the FDA for Vela Ventilator.
| Device ID | K093094 |
| 510k Number | K093094 |
| Device Name: | VELA VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | CARDINAL HEALTH 207, INC. 22745 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Contact | Farokh Etemadieh |
| Correspondent | Farokh Etemadieh CARDINAL HEALTH 207, INC. 22745 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-01 |
| Decision Date | 2010-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 70846446063785 | K093094 | 000 |
| 10190752153448 | K093094 | 000 |
| 10190752153387 | K093094 | 000 |
| 10190752153370 | K093094 | 000 |
| 10190752153363 | K093094 | 000 |
| 10190752153349 | K093094 | 000 |
| 10190752153332 | K093094 | 000 |
| 10190752153325 | K093094 | 000 |
| 10190752153271 | K093094 | 000 |
| 10190752153158 | K093094 | 000 |
| 10190752153141 | K093094 | 000 |
| 10190752153455 | K093094 | 000 |
| 10190752153837 | K093094 | 000 |
| 70846446033368 | K093094 | 000 |
| 70846446010130 | K093094 | 000 |
| 70846446001268 | K093094 | 000 |
| 10846446001693 | K093094 | 000 |
| 10846446001686 | K093094 | 000 |
| 10846446001679 | K093094 | 000 |
| 10846446001242 | K093094 | 000 |
| 10190752175600 | K093094 | 000 |
| 10190752154230 | K093094 | 000 |
| 10190752154223 | K093094 | 000 |
| 10846446001709 | K093094 | 000 |