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FDA 510(k) Application Details - K200763
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K200763
Device Name
Arthroscope
Applicant
IZI Medical
5 Easter Court, Suite J
Owings Mills, MD 21117 US
Other 510(k) Applications for this Company
Contact
Qiang Cao
Other 510(k) Applications for this Contact
Regulation Number
888.1100
More FDA Info for this Regulation Number
Classification Product Code
HRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/24/2020
Decision Date
08/12/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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