The following data is part of a premarket notification filed by Viasys Respiratory Care Inc with the FDA for Avea Ventilator.
| Device ID | K062093 |
| 510k Number | K062093 |
| Device Name: | AVEA VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | VIASYS RESPIRATORY CARE INC 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
| Contact | Tom Gutierrez |
| Correspondent | Tom Gutierrez VIASYS RESPIRATORY CARE INC 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-24 |
| Decision Date | 2006-09-20 |
| Summary: | summary |