510(k) K162041
K162041 is an FDA 510(k) premarket notification submitted by Convexity Scientific, LLC for the device "Airworks Nebulizer pe1200m". The FDA issued a decision of Substantially Equivalent on May 2, 2017. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 2017
- Date Received
- Jul 25, 2016
- 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
- 510(k)