FDA 510(k) Application Details - K013489

Device Classification Name	Meter, Peak Flow, Spirometry   More FDA Info for this Device
510(K) Number	K013489
Device Name	Meter, Peak Flow, Spirometry
Applicant	PDS HEALTHCARE PRODUCTS, INC. 908 MAIN ST. LOUISVILLE, CO 80027 US Other 510(k) Applications for this Company
Contact	JIM LEWIS Other 510(k) Applications for this Contact
Regulation Number	868.1860   More FDA Info for this Regulation Number
Classification Product Code	BZH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/22/2001
Decision Date	11/29/2001
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