FDA 510(k) Application Details - K982675

Device Classification Name	Meter, Peak Flow, Spirometry   More FDA Info for this Device
510(K) Number	K982675
Device Name	Meter, Peak Flow, Spirometry
Applicant	ENACT HEALTH MANAGEMENT SYSTEMS 1975 EL CAMINO REAL WEST, #306 MOUNTAIN VIEW, CA 94040-2218 US Other 510(k) Applications for this Company
Contact	JAMES LYON 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	07/31/1998
Decision Date	10/29/1998
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