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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 K014218
Device Name OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210'
Applicant
DOLPHIN MEDICAL INC.
13801 MCCORMICK DR.
TAMPA,  FL  33626
Applicant Contact JON WERNER
Correspondent
DOLPHIN MEDICAL INC.
13801 MCCORMICK DR.
TAMPA,  FL  33626
Correspondent Contact JON WERNER
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/21/2001
Decision Date 11/07/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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