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FDA 510(k) Application Details - K220514
Device Classification Name
Pad, Heating, Powered
More FDA Info for this Device
510(K) Number
K220514
Device Name
Pad, Heating, Powered
Applicant
MibeTec, GmbH
Munchener Strasse 15
Brehna D-06796 DE
Other 510(k) Applications for this Company
Contact
Oliver Grunert
Other 510(k) Applications for this Contact
Regulation Number
890.5740
More FDA Info for this Regulation Number
Classification Product Code
IRT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/22/2022
Decision Date
06/23/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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