FDA 510(k) Application Details - K053486

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K053486
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	HOFFRICHTER GMBH S65 W35739 PIPER RD. EAGLE, WI 53119 US Other 510(k) Applications for this Company
Contact	STEPHEN H GORSKI 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	12/15/2005
Decision Date	01/04/2006
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