FDA 510(k) Applications for Medical Device Product Code "FLS"
(Monitor, Apnea, Facility Use)

FDA 510(k) Number Applicant Device Name Decision Date
K962865 AIRSEP CORP. REMBRANDT SYSTEM 10/25/1996
K991087 ILIFE SYSTEMS, INC. HANNAH WIRELESS VITAL SIGNS MONITOR 01/12/2000
K951246 PROTOCOL SYSTEMS, INC. PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS 02/02/1996
K011597 RESPIRONICS GEORGIA, INC. SMARTMONITOR 2, MODEL 4000 01/11/2002


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