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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 K143216
Device Name Assurance Alar / Nasal SpO2 Sensor
Applicant
Xhale, Inc.
3630 SW 47th Ave., Suite 100
Gainesville,  FL  32608
Applicant Contact Jeffrey Hoebelheinrich
Correspondent
Xhale, Inc.
3630 SW 47th Ave., Suite 100
Gainesville,  FL  32608
Correspondent Contact Paul Dryden
Regulation Number870.2700
Classification Product Code
DQA  
Date Received11/10/2014
Decision Date 03/17/2015
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
Recalls CDRH Recalls
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