FDA 510(k) Application Details - K180788

Device Classification Name	Spirometer, Monitoring (W/Wo Alarm)   More FDA Info for this Device
510(K) Number	K180788
Device Name	Spirometer, Monitoring (W/Wo Alarm)
Applicant	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD Mindray Building, Keji 12th Road South High-tech Industrial Park, Nanshan Shenzhen 518057 CN Other 510(k) Applications for this Company
Contact	Yanhong Bai Other 510(k) Applications for this Contact
Regulation Number	868.1850   More FDA Info for this Regulation Number
Classification Product Code	BZK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2018
Decision Date	10/24/2018
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