FDA 510(k) Application Details - K000959

Device Classification Name	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)   More FDA Info for this Device
510(K) Number	K000959
Device Name	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Applicant	CARADYNE, LTD. 6329 W. WATERVIEW CT. MCCORDSVILLE, IN 46055 US Other 510(k) Applications for this Company
Contact	PAUL DRYDEN Other 510(k) Applications for this Contact
Regulation Number	868.2600   More FDA Info for this Regulation Number
Classification Product Code	CAP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/24/2000
Decision Date	06/22/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review