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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 K002036
Device Name OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD
Applicant
OSI MEDICAL, INC.
13801 MCCORMICK DR.
TAMPA,  FL  33626
Applicant Contact JAMES R LEVANI
Correspondent
OSI MEDICAL, INC.
13801 MCCORMICK DR.
TAMPA,  FL  33626
Correspondent Contact JAMES R LEVANI
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/05/2000
Decision Date 04/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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