FDA 510(k) Application Details - K982550

Device Classification Name	Monitor, Breathing Frequency   More FDA Info for this Device
510(K) Number	K982550
Device Name	Monitor, Breathing Frequency
Applicant	RESPIRONICS, INC. 1501 ARDMORE BLVD. PITTSBURGH, PA 15221-4401 US Other 510(k) Applications for this Company
Contact	BETSY CORTELLONI Other 510(k) Applications for this Contact
Regulation Number	868.2375   More FDA Info for this Regulation Number
Classification Product Code	BZQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/22/1998
Decision Date	10/05/1998
Decision	ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review