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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 K012989
Device Name DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070
Applicant
DOLPHIN MEDICAL INC.
9433 S. MORNING GLORY LN.
HIGHLANDS RANCH,  CO  80130
Applicant Contact BILL CURNAN
Correspondent
DOLPHIN MEDICAL INC.
9433 S. MORNING GLORY LN.
HIGHLANDS RANCH,  CO  80130
Correspondent Contact BILL CURNAN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/06/2001
Decision Date 03/20/2002
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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