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Precision Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
30
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0272-2016Class IIEasy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15 liter frOctober 8, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K173807Accu O2 Oxygen AnalyzerMay 2, 2018
K140179EASY GO VACApril 25, 2014
K103563PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150July 1, 2011
K103324PRECISION LIQUID OXYGEN SYSTEMApril 21, 2011
K090781HELIO2 BLENDERAugust 13, 2009
K072348PRECISION OXYGEN CONCENTRATOROctober 27, 2008
K063096PRECISION OXYGEN MONITORFebruary 27, 2007
K053232PRECISION BLENDERJanuary 10, 2006
K051691MINIMATE COMPRESSORDecember 9, 2005
K041122PRECISION LIQUID OXYGEN SYSTEMOctober 4, 2004
K032018EASY PULSE II OXYGEN CONSERVERAugust 25, 2003
K001412PM 1800 CONSERVING DEVICEMarch 20, 2001
K971749EASYGO ASPIRATORApril 1, 1998
K944479PM3300 INTERMITTENT VACUUMDecember 22, 1994
K941818PM9000 VAC TRAPDecember 12, 1994
K942350CAREPAKDecember 6, 1994
K930509PM PUMP COMPRESSOROctober 28, 1994
K9320061500 SERIES REGULATOROctober 25, 1993
K932494PM PUMP ASPIRATOROctober 7, 1993
K922817PM3000 & PM3100 VACUUM REGULATORMarch 4, 1993