FDA 510(k) Application Details - K172335

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K172335
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	snapCPAP 143 Harrison Pond Dr. Pittsboro, NC 37312 US Other 510(k) Applications for this Company
Contact	Stuart Heatherington 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	08/02/2017
Decision Date	03/30/2018
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