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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 K060524
Device Name DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES
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 Received02/27/2006
Decision Date 06/15/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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