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FDA 510(k) Application Details - K200984
Device Classification Name
Electrode, Needle
More FDA Info for this Device
510(K) Number
K200984
Device Name
Electrode, Needle
Applicant
Rhythmlink International, LLC
1140 First Street South
Columbia, SC 29209 US
Other 510(k) Applications for this Company
Contact
Gabriel Orsinger
Other 510(k) Applications for this Contact
Regulation Number
882.1350
More FDA Info for this Regulation Number
Classification Product Code
GXZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/14/2020
Decision Date
05/27/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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