The following data is part of a premarket notification filed by Trudell Medical Intl. with the FDA for Solarys Ventilator Aerosol Delivery System (as).
| Device ID | K123614 |
| 510k Number | K123614 |
| Device Name: | SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | TRUDELL MEDICAL INTL. 725 THIRD ST. London, CA N5v 5g4 |
| Contact | Darryl Fischer |
| Correspondent | Darryl Fischer TRUDELL MEDICAL INTL. 725 THIRD ST. London, CA N5v 5g4 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-23 |
| Decision Date | 2013-03-11 |
| Summary: | summary |