510(k) K123614
K123614 is an FDA 510(k) premarket notification submitted by Trudell Medical Intl. for the device "SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)". The FDA issued a decision of Substantially Equivalent on March 11, 2013. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Trudell Medical Intl. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 2013
- Date Received
- November 23, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nebulizer (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5630
- Review Panel
- AN
- Submission Type