FDA 510(k) Application Details - K241395

Device Classification Name Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

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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
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Contact Kai Kroll
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Regulation Number 890.5290

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Classification Product Code ILX
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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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