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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 ROAD
CHANDLER,  AZ  85225
Applicant Contact LUBNA M AHMAD
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
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
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