510(k) K152276

Wing Smart FEVI and Peak Flow Meter by Sparo, Inc. — Product Code BZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2016
Date Received
August 12, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Meter, Peak Flow, Spirometry
Device Class
Class II
Regulation Number
868.1860
Review Panel
AN
Submission Type