Heartsine Technologies, Limited

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-2115-2014Class IIPad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and June 12, 2014
Z-0124-2013Class IHeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A0003500September 13, 2012