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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
S65w35739 Piper Rd.
Egale,  WI  53119
Applicant Contact STEPHEN H GORSKI
Correspondent
Shenzhen Envisen Industry Co. Limited
S65w35739 Piper Rd.
Egale,  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
Predetermined Change
Control Plan Authorized		 No
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