FDA 510(k) Application Details - K050853

Device Classification Name	Meter, Peak Flow, Spirometry   More FDA Info for this Device
510(K) Number	K050853
Device Name	Meter, Peak Flow, Spirometry
Applicant	CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST. REHOVOT 76100 IL Other 510(k) Applications for this Company
Contact	NA'AMA OREN Other 510(k) Applications for this Contact
Regulation Number	868.1860   More FDA Info for this Regulation Number
Classification Product Code	BZH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/04/2005
Decision Date	05/04/2005
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