FDA 510(k) Application Details - K241661

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K241661
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	Sleepnet Corporation 5 Merrill Industrial Drive Hampton, NH 03842 US Other 510(k) Applications for this Company
Contact	Jennifer Kennedy Other 510(k) Applications for this Contact
Regulation Number	868.5905   More FDA Info for this Regulation Number
Classification Product Code	BZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/10/2024
Decision Date	07/10/2024
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