510(k) K111570

MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR by Thayer Medical Corporation — Product Code CAF

K111570 is an FDA 510(k) premarket notification submitted by Thayer Medical Corporation for the device "MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR". The FDA issued a decision of Substantially Equivalent on September 29, 2011. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Thayer Medical Corporation has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2011
Date Received
June 6, 2011
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