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FDA 510(k) Application Details - K183182
Device Classification Name
More FDA Info for this Device
510(K) Number
K183182
Device Name
Critical Care Suite
Applicant
GE Medical Systems, LLC.
3000 N. Grandview Blvd
Waukesha, WI 53188 US
Other 510(k) Applications for this Company
Contact
Camille Vidal
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QFM
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More FDA Info for this Product Code
Date Received
11/19/2018
Decision Date
08/12/2019
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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