FDA 510(k) Application Details - K000888

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K000888
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	PRYM MEDICAL LTD. 117 AHUZAH ST. RA'ANANNA 43373 IL Other 510(k) Applications for this Company
Contact	SHOSHANA FRIEDMAN 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	03/20/2000
Decision Date	08/15/2000
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