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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
Xhale, Inc
3630 SW 47th Ave, Suite 100
Gainesville,  FL  32608
Applicant Contact Jeffrey Hoebelheinrich
Xhale, Inc. c/o ProMedic, LLC
24301 Woodsage Dr.
Bonita Springs,  FL  34134
Correspondent Contact Paul Dryden
Regulation Number870.2700
Classification Product Code
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
Recalls CDRH Recalls