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FDA 510(k) Application Details - K200074
Device Classification Name
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510(K) Number
K200074
Device Name
O-arm O2 Imaging System
Applicant
Medtronic Inc.
300 Foster St.
Littleton, MA 01460 US
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Contact
Dean Honkonen
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Regulation Number
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Classification Product Code
OWB
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More FDA Info for this Product Code
Date Received
01/14/2020
Decision Date
04/24/2020
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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