Medical Device Manufacturer · US , Washington , DC

Itamar Medical , Ltd. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2011

Total

Cleared

Denied

FDA 510(k) Regulatory Record - Itamar Medical , Ltd. Cardiovascular ✕

1 devices

1-1 of 1

Linked clinical trials FDA-regulated device evidence

Regulatory consultant 510(k) submission support ecosystem

Hogan Lovells US LLP

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Clinical validation data available

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: Apr 27, 2026