FDA 510(k) Application Details - K243268

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K243268
Device Name	Ventilatory Effort Recorder
Applicant	PranaQ Pte. Ltd. 331 North Bridge Road #12-03, Odeon Towers Singapore 188720 SG Other 510(k) Applications for this Company
Contact	Jerry Chen Other 510(k) Applications for this Contact
Regulation Number	868.2375   More FDA Info for this Regulation Number
Classification Product Code	MNR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/2024
Decision Date	02/03/2025
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