FDA 510(k) Application Details - K100687

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K100687
Device Name	Spirometer, Diagnostic
Applicant	VITALOGRAPH(IRELAND) LTD. ENNIS INDUSTRIAL ESTATE GORT ROAD BUSINESS PARK ENNIS, CO. CLARE IE Other 510(k) Applications for this Company
Contact	TOM J HEALY 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	03/10/2010
Decision Date	10/16/2010
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