FDA 510(k) Application Details - K244027

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K244027
Device Name	Ventilatory Effort Recorder
Applicant	Huxley Medical 1465 Northside Dr. NW Suite 217 Atlanta, GA 30318 US Other 510(k) Applications for this Company
Contact	Daniel Burnham 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	12/30/2024
Decision Date	01/28/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review