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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 K920390
Device Name THE PEAK
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 Number868.1860
Classification Product Code
BZH  
Date Received01/30/1992
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
Predetermined Change
Control Plan Authorized		 No
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