510(k) K192724

Propeller Sensor for Symbicort by Reciprocal Labs Corporation — Product Code CAF

K192724 is an FDA 510(k) premarket notification submitted by Reciprocal Labs Corporation for the device "Propeller Sensor for Symbicort". The FDA issued a decision of Substantially Equivalent on Mar 26, 2020. 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
Mar 26, 2020
Date Received
Sep 27, 2019
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)