FDA 510(k) Application Details - K053156

Device Classification Name	Meter, Peak Flow, Spirometry   More FDA Info for this Device
510(K) Number	K053156
Device Name	Meter, Peak Flow, Spirometry
Applicant	CLEMENT CLARKE INTL., LTD. EDINBURGH WAY HARLOW, ESSEX CM20 2TT GB Other 510(k) Applications for this Company
Contact	PHILIP HALLYBONE 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	11/14/2005
Decision Date	01/31/2006
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