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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 K030952
Device Name DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421
Applicant
Dolphin Medical, Inc.
9433 S. Morning Glory Ln.
Littleton,  CO  80130
Applicant Contact BILL CURNAN
Correspondent
Dolphin Medical, Inc.
9433 S. Morning Glory Ln.
Littleton,  CO  80130
Correspondent Contact BILL CURNAN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/26/2003
Decision Date 05/19/2003
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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