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FDA 510(k) Application Details - K192819
Device Classification Name
More FDA Info for this Device
510(K) Number
K192819
Device Name
OEC Elite
Applicant
GE OEC Medical Systems, Inc.
384 N Wright Brothers Drive
Salt Lake City, UT 84116 US
Other 510(k) Applications for this Company
Contact
Kenny M Bello
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
OXO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/01/2019
Decision Date
11/08/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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