FDA 510(k) Application Details - K203502

Device Classification Name	More FDA Info for this Device
510(K) Number	K203502
Device Name	MEDO-Thyroid
Applicant	MEDO DX Pte. Ltd. 4560 TEC Centre, 10230 Jasper Avenue Edmonton T5J4P6 CA Other 510(k) Applications for this Company
Contact	Dornoosh Zonoobi 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	11/30/2020
Decision Date	04/23/2021
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