FDA 510(k) Application Details - K241520

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K241520
Device Name	Ventilator, Continuous, Facility Use
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	868.5895   More FDA Info for this Regulation Number
Classification Product Code	CBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/29/2024
Decision Date	06/27/2024
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