FDA 510(k) Application Details - K972086

Device Classification Name	Spirometer, Monitoring (W/Wo Alarm)   More FDA Info for this Device
510(K) Number	K972086
Device Name	Spirometer, Monitoring (W/Wo Alarm)
Applicant	ALEXANDER MFG. CO. 1511 S GARFIELD PL MASON CITY, IA 50401 US Other 510(k) Applications for this Company
Contact	KEN HEIMENDINGER Other 510(k) Applications for this Contact
Regulation Number	868.1850   More FDA Info for this Regulation Number
Classification Product Code	BZK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/04/1997
Decision Date	08/12/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review