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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 K061706
Device Name CADWELL EASYNET OXIMETER MODULE
Applicant
Cadwell Laboratories, Inc.
909 N Kellogg St.
Kennewick,  WA  99336
Applicant Contact CHRIS BOLKAN
Correspondent
Cadwell Laboratories, Inc.
909 N Kellogg St.
Kennewick,  WA  99336
Correspondent Contact CHRIS BOLKAN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received06/16/2006
Decision Date 03/05/2007
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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