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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
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