FDA 510(k) Application Details - K243966

Device Classification Name	Monitor, Breathing Frequency   More FDA Info for this Device
510(K) Number	K243966
Device Name	Monitor, Breathing Frequency
Applicant	FaceHeart Corp. PO Box 309, Ugland House Grand Cayman KY1-1104 KY Other 510(k) Applications for this Company
Contact	Dr. Meng Liang Chung 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	12/23/2024
Decision Date	04/09/2025
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