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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 K913790
Device Name SENSORMEDICS OXYSHUTTLE II(TM)
Applicant
Sensor Medics Corp.
22705 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Applicant Contact DAVID M TRUEBLOOD
Correspondent
Sensor Medics Corp.
22705 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Correspondent Contact DAVID M TRUEBLOOD
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/23/1991
Decision Date 02/26/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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