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510(k) K012387

STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM by Stethographics, Inc. — Product Code BZM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2002
Date Received
July 27, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Pulmonary Function Interpretor (Diagnostic)
Device Class
Class II
Regulation Number
868.1900
Review Panel
AN
Submission Type

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