The following data is part of a premarket notification filed by Carefusion with the FDA for Avea Ventilator.
| Device ID | K103211 |
| 510k Number | K103211 |
| Device Name: | AVEA VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | CAREFUSION 22745 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Contact | Farokh Etemadieh |
| Correspondent | Farokh Etemadieh CAREFUSION 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 | 2010-11-01 |
| Decision Date | 2011-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 70846446001275 | K103211 | 000 |
| 10190752158320 | K103211 | 000 |
| 10190752158290 | K103211 | 000 |
| 10190752156258 | K103211 | 000 |
| 10190752156210 | K103211 | 000 |
| 10190752156203 | K103211 | 000 |
| 10846446011913 | K103211 | 000 |
| 10190752177048 | K103211 | 000 |
| 10190752174801 | K103211 | 000 |
| 10190752157767 | K103211 | 000 |
| 10190752186439 | K103211 | 000 |
| 20190752156231 | K103211 | 000 |
| 10846446015973 | K103211 | 000 |
| 10190752186521 | K103211 | 000 |
| 10190752186248 | K103211 | 000 |
| 10190752185784 | K103211 | 000 |
| 10190752185685 | K103211 | 000 |
| 10190752158351 | K103211 | 000 |
| 10190752186873 | K103211 | 000 |
| 10190752187757 | K103211 | 000 |
| 10846446001174 | K103211 | 000 |
| 10846446001143 | K103211 | 000 |
| 10846446015966 | K103211 | 000 |
| 10190752158313 | K103211 | 000 |
| 10190752156838 | K103211 | 000 |
| 10190752156227 | K103211 | 000 |
| 10190752185777 | K103211 | 000 |
| 10190752175921 | K103211 | 000 |
| 10190752159051 | K103211 | 000 |
| 10190752156814 | K103211 | 000 |
| 10190752156272 | K103211 | 000 |
| 10190752128668 | K103211 | 000 |
| 10190752160385 | K103211 | 000 |
| 10190752128651 | K103211 | 000 |
| 10190752167117 | K103211 | 000 |
| 10190752159075 | K103211 | 000 |
| 10190752157071 | K103211 | 000 |