FDA 510(k) Application Details - K203785

Device Classification Name	More FDA Info for this Device
510(K) Number	K203785
Device Name	ClariSIGMAM
Applicant	ClariPi Inc. 3F, 70-15, Ihwajang-gil Seoul 03088 KR Other 510(k) Applications for this Company
Contact	Hyun-Sook Park Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/28/2020
Decision Date	09/10/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review