FDA 510(k) Application Details - K011516

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K011516
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	EME (ELECTRO MEDICAL EQUIPMENT) LTD. 60 GLADSTONE PLACE BRIGHTON, SUSSEX BN2 3QD GB Other 510(k) Applications for this Company
Contact	STUART CORNER 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	05/17/2001
Decision Date	06/08/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review