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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 K915451
Device Name MULTISPIRO-SX
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 Number868.1840
Classification Product Code
BZG  
Date Received12/05/1991
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
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