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Transoma Medical

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K091206SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) May 18, 2009
K073147SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08December 3, 2007