Sigma

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2030-2012Class IIISIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customApril 23, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K962239SMART ADJUSTER (SA201)January 10, 1997
K926191SIGMA 7000 AND SIGMA70002August 31, 1993
K851738MCDB-105 MED. M6395, W/L-GLUTAMINE, 25M M HERPES &May 15, 1985
K851737MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES &May 15, 1985
K830038SIGMA 7000-6000 INFUSION PUMPSJanuary 26, 1983
K820038SIGMA 7000January 26, 1983