FDA 510(k) Application Details - K160950

Device Classification Name	Apparatus, Gas-Scavenging   More FDA Info for this Device
510(K) Number	K160950
Device Name	Apparatus, Gas-Scavenging
Applicant	Sedation Systems LLC 2471 McMullen Booth Rd, Ste. 316 Clearwater, FL 33759 US Other 510(k) Applications for this Company
Contact	S. Michael Bender Other 510(k) Applications for this Contact
Regulation Number	868.5430   More FDA Info for this Regulation Number
Classification Product Code	CBN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/05/2016
Decision Date	05/05/2017
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