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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 K123945
Device Name STRIVE DUAL ZONE PEAK FLOW METER
Applicant
Monaghan Medical Corp.
5 Latour Ave., Suite 1600
Plattsburgh,  NY  12901
Applicant Contact CARI J REIL
Correspondent
Monaghan Medical Corp.
5 Latour Ave., Suite 1600
Plattsburgh,  NY  12901
Correspondent Contact CARI J REIL
Regulation Number868.1860
Classification Product Code
BZH  
Date Received12/21/2012
Decision Date 04/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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