510(k) K121609
K121609 is an FDA 510(k) premarket notification submitted by Reciprocal Labs Corporation for the device "ASTHMAPOLIS SYSTEM". The FDA issued a decision of Substantially Equivalent on Jul 2, 2012. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Reciprocal Labs Corporation has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 2, 2012
- Date Received
- Jun 1, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Nebulizer (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5630
- Review Panel
- AN
- Submission Type
- 510(k)