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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 K875027
Device Name STAR CALC
Applicant
Infrasonics Corp.
9944 Barnes Canyon Rd.
San Diego,  CA  92121
Applicant Contact JIM HITCHIN
Correspondent
Infrasonics Corp.
9944 Barnes Canyon Rd.
San Diego,  CA  92121
Correspondent Contact JIM HITCHIN
Regulation Number868.1880
Classification Product Code
BZC  
Date Received12/07/1987
Decision Date 08/16/1988
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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