FDA 510(k) Application Details - K161411

Device Classification Name	Accessory To Continuous Ventilator (Respirator)   More FDA Info for this Device
510(K) Number	K161411
Device Name	Accessory To Continuous Ventilator (Respirator)
Applicant	RESPIRONICS, INC. 1001 MURRY RIDGE LN. MURRYSVILLES, PA 15668 US Other 510(k) Applications for this Company
Contact	Colleen Witt Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	MOD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/2016
Decision Date	02/17/2017
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