FDA 510(k) Application Details - K953363

Device Classification Name	Monitor, Breathing Frequency   More FDA Info for this Device
510(K) Number	K953363
Device Name	Monitor, Breathing Frequency
Applicant	EDENTEC CORP. 10252 VALLEY VIEW RD. EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	CHRIS HADLAND 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	07/17/1995
Decision Date	02/06/1996
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