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FDA 510(k) Application Details - K233678
Device Classification Name
System, X-Ray, Mobile
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
892.1720
More FDA Info for this Regulation Number
Classification Product Code
IZL
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More FDA Info for this Product Code
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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