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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Breath Measurement
510(k) Number K963376
Device Name MICRO H2
Applicant
Micro Direct, Inc.
P.O. Box 239
840 Pownal Rd.
Auburn,  ME  04210
Applicant Contact DAVID STASZAK
Correspondent
Micro Direct, Inc.
P.O. Box 239
840 Pownal Rd.
Auburn,  ME  04210
Correspondent Contact DAVID STASZAK
Regulation Number862.1820
Classification Product Code
NRH  
Date Received08/27/1996
Decision Date 01/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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