FDA 510(k) Application Details - K043528

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K043528
Device Name	Spirometer, Diagnostic
Applicant	MIR MEDICAL INTL. RESEARCH SRL VIA DEL MAGGIOLINO 125 ROMA 00155 IT Other 510(k) Applications for this Company
Contact	SIMON FOWLER Other 510(k) Applications for this Contact
Regulation Number	868.1840   More FDA Info for this Regulation Number
Classification Product Code	BZG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2004
Decision Date	07/19/2005
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