FDA 510(k) Application Details - K233126

Device Classification Name	More FDA Info for this Device
510(K) Number	K233126
Device Name	aetherSlide
Applicant	aetherAI Co., Ltd. 15F & 15F-1., No. 508, Sec. 7 Zhongxiao E. Rd., Nangang Dist. Taipei City 115011 TW Other 510(k) Applications for this Company
Contact	Leticia Hong Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QKQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2023
Decision Date	05/30/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review