FDA 510(k) Application Details - K033518

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K033518
Device Name	Spirometer, Diagnostic
Applicant	CUSTOM PLASTIC PRODUCTS 28481 LA FALDA LAGUNA NIGUEL, CA 92677 US Other 510(k) Applications for this Company
Contact	JIM BARLEY 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	11/07/2003
Decision Date	03/10/2004
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