FDA 510(k) Application Details - K191364

Device Classification Name	System, Automated Platelet Aggregation   More FDA Info for this Device
510(K) Number	K191364
Device Name	System, Automated Platelet Aggregation
Applicant	Fujimori Kogyo Co., Ltd. Shinjuku First West 1-23-7 Nishi-Shinjuku Shinjuku, Tokyo 160-0023 JP Other 510(k) Applications for this Company
Contact	Jeffrey Dahlen Other 510(k) Applications for this Contact
Regulation Number	864.5700   More FDA Info for this Regulation Number
Classification Product Code	JOZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/22/2019
Decision Date	02/14/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review