FDA 510(k) Application Details - K173187

Device Classification Name System, X-Ray, Mobile

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510(K) Number K173187
Device Name System, X-Ray, Mobile
Applicant Philips India Limited
Plot No. B-79, MIDC, Phase II, Chakan, Taluka-Khed
Village - Savardari
Pune 410501 IN
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Contact Nidhi Bathwal
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Regulation Number 892.1720

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Classification Product Code IZL
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Date Received 10/02/2017
Decision Date 11/16/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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