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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 K031465
Device Name MODEL 2100 PULSE OXIMETER
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 Received05/08/2003
Decision Date 10/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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