FDA 510(k) Application Details - K042758

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K042758
Device Name	Spirometer, Diagnostic
Applicant	POLYTECHNIC RESOURCES, INC. 1107 MIDDLE RIVER ROAD SUITE B-1 BALTIMORE, MD 21220 US Other 510(k) Applications for this Company
Contact	TIMOTHY BYRD 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	10/04/2004
Decision Date	08/29/2005
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