FDA 510(k) Application Details - K233415

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K233415
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	RemSleep Holdings 14175 Icot Blvd Clearwater, FL 33760 US Other 510(k) Applications for this Company
Contact	Tom Wood 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	10/10/2023
Decision Date	07/02/2024
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