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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 interpretor (diagnostic)
510(k) Number K012387
Device Name STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM
Applicant
STETHOGRAPHICS, INC.
11874 S. EVELYN CIRCLE
HOUSTON,  TX  77071
Applicant Contact HARVEY KNAUSS
Correspondent
STETHOGRAPHICS, INC.
11874 S. EVELYN CIRCLE
HOUSTON,  TX  77071
Correspondent Contact HARVEY KNAUSS
Regulation Number868.1900
Classification Product Code
BZM  
Date Received07/27/2001
Decision Date 04/23/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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