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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 K051450
Device Name EXTENDED MEASUREMENTS SYSTEM
Applicant
INOVISE MEDICAL, INC.
10565 SW NIMBUS AVE.
SUITE 100
PORTLAND,  OR  97223
Applicant Contact STEVE C HESLER
Correspondent
INOVISE MEDICAL, INC.
10565 SW NIMBUS AVE.
SUITE 100
PORTLAND,  OR  97223
Correspondent Contact STEVE C HESLER
Regulation Number870.1875
Classification Product Code
DQD  
Date Received06/02/2005
Decision Date 11/10/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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