Accutron Inc

FDA Regulatory Profile

Summary

Total Recalls
4 (4 Class I)
510(k) Clearances
5
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0018-2013Class IUltra PC% Cabinet Mount Package G, Model #36600, Serial # 13593, 13594, 13595, 13596, 13597, 13598April 29, 2012
Z-0020-2013Class INewport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, April 29, 2012
Z-0017-2013Class IFlow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793. Flowmeter, CM AssemblApril 29, 2012
Z-0019-2013Class ICM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit AnalApril 29, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K052335ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRANovember 23, 2005
K033503RFS VACUUM GAUGE SCAVENGING CIRCUITMarch 12, 2004
K992421GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076October 27, 1999
K965239PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261March 28, 1997
K970046UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550)March 28, 1997