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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter, Reprocessed
510(k) Number K012609
Device Name CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25
Applicant
Clearmedical, Inc.
1776 136th Pl. NE
Bellevue,  WA  98005
Applicant Contact RICHARD RADFORD
Correspondent
Clearmedical, Inc.
1776 136th Pl. NE
Bellevue,  WA  98005
Correspondent Contact RICHARD RADFORD
Regulation Number870.2700
Classification Product Code
NLF  
Date Received08/13/2001
Decision Date 07/03/2002
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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