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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 K881307
Device Name OLV 1100; OLV 1200 PULSE OXIMETERS
Original Applicant
17112 armstrong ave.
irvine,  CA  92714
Original Contact mike dashefsky
Regulation Number870.2700
Classification Product Code
Date Received03/28/1988
Decision Date 11/04/1988
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No