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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spirometer, diagnostic
510(k) Number K863134
Device Name MULTISPIRO SA/100
Applicant
BIOTRINE CORP.
52 DRAGON CT
WOBURN,  MA  01801
Applicant Contact JOHN BURKE
Correspondent
BIOTRINE CORP.
52 DRAGON CT
WOBURN,  MA  01801
Correspondent Contact JOHN BURKE
Regulation Number868.1840
Classification Product Code
BZG  
Date Received08/15/1986
Decision Date 12/15/1986
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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