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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 K122996
Device Name ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085
Applicant
XHALE
701 HEBRON AVENUE
GLASTONBURY,  CT  06033
Applicant Contact DAVID RICH
Correspondent
XHALE
701 HEBRON AVENUE
GLASTONBURY,  CT  06033
Correspondent Contact DAVID RICH
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
DSA  
Date Received09/27/2012
Decision Date 04/10/2013
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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