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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Oxygen-Uptake
510(k) Number K110810
Device Name ANASCIENT BREATH MONITOR
Applicant
Invoy Technologies, LLC
1820 E.Ray Rd.
Chandler,  AZ  85225
Applicant Contact LUBNA M AHMAD
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact BHAVESH V SHETH
Regulation Number868.1730
Classification Product Code
BZL  
Date Received03/23/2011
Decision Date 06/21/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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