FDA 510(k) Application Details - K202788

Device Classification Name	Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat   More FDA Info for this Device
510(K) Number	K202788
Device Name	Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Applicant	Carci Industria E Comercio De Aparelhos Cirurgicos E Orto R. Padre Machado, 82 Sao Paulo 04127 BR Other 510(k) Applications for this Company
Contact	Orlando Orlandi Other 510(k) Applications for this Contact
Regulation Number	890.5300   More FDA Info for this Regulation Number
Classification Product Code	IMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/22/2020
Decision Date	12/23/2021
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