Penlon, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
19
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1653-2013Class IIDelta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliveMay 14, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K061102PRIMA ANAESTHESIA MACHINEJuly 28, 2006
K041076DELTA TAugust 9, 2004
K010318PRIMA OXYGEN MONITORJuly 23, 2001
K010317AV 800 VENTILATORJuly 23, 2001
K002343SIGMA DELTAJune 8, 2001
K961468QUIK-FIL VAPORIZER KEYED FILLERJuly 16, 1996
K960944PPV VAPORIZER (MODIFICATION)April 2, 1996
K953179CLM LARYNGOSCOPEOctober 6, 1995
K942545SIGMA ELITEFebruary 3, 1995
K936046SIGMA ELITENovember 4, 1994
K902381PENLON BREATHING SYSTEM PRESSURE MONITORAugust 17, 1990
K894689PENLON IDP PRESSURE FAILURE ALARMAugust 10, 1989
K844007PENLON PPV VAPORIZERMarch 12, 1985
K844008PENLON AM1000 ANAESTHESIA MACHINEMarch 12, 1985
K823555MAGTARAK RESPIRATORY MONITOR & FLOW SENSJanuary 5, 1983
K803052NUFFIELD ANESTHESIA VENTILATOR SER. 400January 7, 1981
K801253CREST ELECTRONIC WARMING BLANKETJanuary 2, 1981
K801254PENLON I.D.P. PRESSSURE FAILURE ALARMJune 9, 1980
K801255PENLON JUMBO CARBON DIOXIDE ABSORBERJune 4, 1980