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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 K033876
Device Name DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422
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 Received12/15/2003
Decision Date 03/11/2004
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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