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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 K171423
Device Name Nasal Alar SpO2 Sensor
Applicant
Xhale, Inc.
3630 SW 47th Ave., Suite 100
Gainesville,  FL  32608
Applicant Contact Jeffrey Hoebelheinrich
Correspondent
Xhale, Inc. C/O Promedic, LLC
24301 Woodsage Dr.
Bonita Springs,  FL  34134
Correspondent Contact Paul Dryden
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/15/2017
Decision Date 07/27/2017
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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