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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 K023097
Device Name TRUEZONE PEAK FLOW METER
Applicant
Monaghan Medical Corp.
5 Latour Ave., Suite 1600
P.O. Box 2805
Plattsburgh,  NY  12901
Applicant Contact JAMES A COCHIE
Correspondent
Monaghan Medical Corp.
5 Latour Ave., Suite 1600
P.O. Box 2805
Plattsburgh,  NY  12901
Correspondent Contact JAMES A COCHIE
Regulation Number868.1860
Classification Product Code
BZH  
Date Received09/18/2002
Decision Date 03/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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