FDA 510(k) Application Details - K190775

Device Classification Name	Monitor, Breathing Frequency   More FDA Info for this Device
510(K) Number	K190775
Device Name	Monitor, Breathing Frequency
Applicant	Shenzhen Fiber Medical Technology Co. Ltd. Room 501, Sun Mate Science and Technology Mansion 2009 Shahe West Road Shenzhen 518057 CN Other 510(k) Applications for this Company
Contact	Luo Li Other 510(k) Applications for this Contact
Regulation Number	868.2375   More FDA Info for this Regulation Number
Classification Product Code	BZQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2019
Decision Date	12/19/2019
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