Fluke Biomedical

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
9
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K121860ESA615January 25, 2013
K121722ESA620 ELECTRICAL SAFETY ANALYZEROctober 11, 2012
K110429PROSIM 4, PROSIM 6, PROSIM 8September 2, 2011
K103336MPS450 MULTIPARAMETER SIMULATORApril 13, 2011
K083347IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADSDecember 24, 2008
K072114IMPULSE 6000D/7000DPJanuary 28, 2008