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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter
510(k) Number K103584
Device Name ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS
Applicant
SHENZHEN ENVISEN INDUSTRY CO. LIMITED
S65 W35739 PIPER ROAD
EAGLE,  WI  53119
Applicant Contact STEPHEN H GORSKI
Correspondent
SHENZHEN ENVISEN INDUSTRY CO. LIMITED
S65 W35739 PIPER ROAD
EAGLE,  WI  53119
Correspondent Contact STEPHEN H GORSKI
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/07/2010
Decision Date 06/10/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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