FDA 510(k) Application Details - K143216

Device Classification Name Oximeter

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510(K) Number K143216
Device Name Oximeter
Applicant Xhale, Inc.
3630 SW 47th Ave, Suite 100
Gainesville, FL 32608 US
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Contact Jeffrey Hoebelheinrich
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 11/10/2014
Decision Date 03/17/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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