FDA 510(k) Application Details - K233336

Device Classification Name	More FDA Info for this Device
510(K) Number	K233336
Device Name	21.3ö 3MP Color LCD Display UMD3-21B01 (MD3-21B01)
Applicant	ACULA Technology Corp 11, Alley 21, Lane 20, Rd. Dashing, Luchu Dist. Taoyuan 33862 TW Other 510(k) Applications for this Company
Contact	Sheng-Sung Jian Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2023
Decision Date	05/21/2024
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