FDA 510(k) Application Details - K231561

Device Classification Name	Calculator, Predicted Values, Pulmonary Function   More FDA Info for this Device
510(K) Number	K231561
Device Name	Calculator, Predicted Values, Pulmonary Function
Applicant	Guangzhou Homesun Medical Technology Co., Ltd Floor 7th, Tianxiang Business Building, No.28, Li Fu Road Haizhu District Guangzhou City 510250 CN Other 510(k) Applications for this Company
Contact	Suijie Huang Other 510(k) Applications for this Contact
Regulation Number	868.1890   More FDA Info for this Regulation Number
Classification Product Code	BTY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2023
Decision Date	02/21/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review