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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 K862617
Device Name SENSORMEDICS OXYSHUTTLE(TM)
Applicant
Sensor Medics Corp.
1630 S. State College Blvd.
Anaheim,  CA  92806
Applicant Contact MERTON A ROBINSON
Correspondent
Sensor Medics Corp.
1630 S. State College Blvd.
Anaheim,  CA  92806
Correspondent Contact MERTON A ROBINSON
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/09/1986
Decision Date 09/26/1986
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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