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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 K030586
Device Name MICROPEAK
Applicant
Micro Direct, Inc.
803 Webster St.
Lewiston,  ME  04240
Applicant Contact DAVID R STASZAK
Correspondent
Micro Direct, Inc.
803 Webster St.
Lewiston,  ME  04240
Correspondent Contact DAVID R STASZAK
Regulation Number868.1860
Classification Product Code
BZH  
Date Received02/24/2003
Decision Date 08/27/2003
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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