Medical Device Manufacturer · US , Naples , FL

Heart Sync, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2012

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Heart Sync, Inc. Cardiovascular ✕

3 devices

1-3 of 3

Cleared Dec 06, 2013

Cardiovascular · 191d

Cleared Sep 16, 2013

Cardiovascular · 116d

Cleared Aug 06, 2012

HEART SYNC PEDIATRIC PHYSIO AED PAD

Cardiovascular · 166d