FDA 510(k) Application Details - K980951

Device Classification Name	Meter, Peak Flow, Spirometry   More FDA Info for this Device
510(K) Number	K980951
Device Name	Meter, Peak Flow, Spirometry
Applicant	STI MEDICAL 908 POMPTON AVE. CEDAR GROVE, NJ 07009 US Other 510(k) Applications for this Company
Contact	LAUREN R ZIEGLER 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	03/13/1998
Decision Date	02/25/2000
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