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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 K915060
Device Name ASTECH HOME PEAK FLOW METER
Applicant
BIOTRINE CORP.
52 DRAGON CT
WOBURN,  MA  01801
Applicant Contact JOHN W.BURKE
Correspondent
BIOTRINE CORP.
52 DRAGON CT
WOBURN,  MA  01801
Correspondent Contact JOHN W.BURKE
Regulation Number868.1860
Classification Product Code
BZH  
Date Received11/08/1991
Decision Date 09/11/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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