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FDA 510(k) Application Details - K211161
Device Classification Name
More FDA Info for this Device
510(K) Number
K211161
Device Name
Critical Care Suite with Endotracheal Tube Positing AI algorithm
Applicant
GE Medical Systems, LLC
3000 N. Grandview Blvd
Waukesha, WI 53188 US
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Contact
Chris Paulik
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Regulation Number
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Classification Product Code
QIH
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Date Received
04/19/2021
Decision Date
10/29/2021
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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