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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 K100077
Device Name NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103
Applicant
Solaris Medical Technology, Inc.
400 Oyster Pt. Blvd.
Suite 534
South San Francisco,  CA  94080
Applicant Contact RACHEL CHENG
Correspondent
Solaris Medical Technology, Inc.
400 Oyster Pt. Blvd.
Suite 534
South San Francisco,  CA  94080
Correspondent Contact RACHEL CHENG
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/12/2010
Decision Date 10/07/2010
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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