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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K082528
Device Name SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM
Applicant
Noble Anesthesia-Air, Inc.
277 Zane Court
Hillside Village
Elizabeth,  CO  80107
Applicant Contact ALEXANDER B HENDERSON
Correspondent
Noble Anesthesia-Air, Inc.
277 Zane Court
Hillside Village
Elizabeth,  CO  80107
Correspondent Contact ALEXANDER B HENDERSON
Regulation Number870.1875
Classification Product Code
DQD  
Date Received09/02/2008
Decision Date 03/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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