FDA 510(k) Application Details - K233678

Device Classification Name System, X-Ray, Mobile

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510(K) Number K233678
Device Name System, X-Ray, Mobile
Applicant Philips Medical Systems DMC GmbH
R÷ntgenstra▀e 24
Hamburg 22335 DE
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Contact Shalin Dave
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Regulation Number 892.1720

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Classification Product Code IZL
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Date Received 11/16/2023
Decision Date 02/14/2024
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

FDA Source Information for K233678


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