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FDA 510(k) Application Details - K241395
Device Classification Name
Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
More FDA Info for this Device
510(K) Number
K241395
Device Name
Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Applicant
Caerus Corporation
8611 W 35W Service Dr NE
Suite 180
Blaine, MN 55449 US
Other 510(k) Applications for this Company
Contact
Kai Kroll
Other 510(k) Applications for this Contact
Regulation Number
890.5290
More FDA Info for this Regulation Number
Classification Product Code
ILX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/16/2024
Decision Date
12/18/2024
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
FDA Source Information for K241395
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