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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 K012533
Device Name MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER AND ACCESSORIES
Applicant
OSI MEDICAL, INC.
13801 MCCORMICK DR.
TAMPA,  FL  33626
Applicant Contact JON WERNER
Correspondent
OSI MEDICAL, INC.
13801 MCCORMICK DR.
TAMPA,  FL  33626
Correspondent Contact JON WERNER
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/06/2001
Decision Date 08/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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