FDA 510(k) Application Details - K232985

Device Classification Name

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510(K) Number K232985
Device Name 24HR513C
Applicant LG Electronics Inc.
168, Suchul-daero
Gumi-si 39368 KR
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Contact Jinhwan Jun
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Regulation Number

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Classification Product Code PGY
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Date Received 09/22/2023
Decision Date 12/11/2023
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 K232985


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