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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name meter, peak flow, spirometry
510(k) Number K152276
Device Name Wing Smart FEVI and Peak Flow Meter
Sparo Inc.
911 Washington Ave, #809
Saint Louis,  MO  63101
Applicant Contact Mona Dean
Sparo Inc.
911 Washington Ave, #809
Saint Louis,  MO  63101
Correspondent Contact Mona Dean
Regulation Number868.1860
Classification Product Code
Date Received08/12/2015
Decision Date 06/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No