Heartsine Technologies, Inc. is one of 19088 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Heartsine Technologies, Inc. - FDA 510(k) Cleared Devices
Recent clearances: samaritan PAD 450P, HEARTSINE SAMARITAN PAD 350P, REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351
6
Total
6
Cleared
0
Denied
Heartsine Technologies, Inc. has 6 FDA 510(k) cleared medical devices. Based in Mission Viejo, US.
Historical record: 6 cleared submissions from 2003 to 2015. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Heartsine Technologies, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Regulatory Strategies, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Heartsine Technologies, Inc.
6 devices
Cleared
Mar 27, 2015
samaritan PAD 450P
Cardiovascular
186d
Cleared
Jul 11, 2013
HEARTSINE SAMARITAN PAD 350P
Cardiovascular
206d
Cleared
Dec 12, 2006
REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS...
Cardiovascular
460d
Cleared
Sep 02, 2004
SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301
Cardiovascular
30d
Cleared
May 25, 2004
HEARTSINE SAMARITAN PAD
Cardiovascular
32d
Cleared
Feb 14, 2003
SAMARITAN AED, MODEL SAM-01
Cardiovascular
87d