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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Pulmonary Function Data
510(k) Number K913681
Device Name MULTISPIRO-BREEZE
Applicant
MULTISPIRO, INC.
9A MASON
IRVINE,  CA  92718
Applicant Contact DANIEL BROWN
Correspondent
MULTISPIRO, INC.
9A MASON
IRVINE,  CA  92718
Correspondent Contact DANIEL BROWN
Regulation Number868.1880
Classification Product Code
BZC  
Date Received08/19/1991
Decision Date 07/02/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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