Medical Device Manufacturer · US , Gaithersburg , MD

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

3 submissions · 3 cleared · Since 2014

Recent clearances: MiniBox +, PULMONE MINIBOXPFT 2.0, PULMONE MINIBOX PFT TM

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Pulmone Advanced Medical Devices, Ltd. Anesthesiology ✕

3 devices

1-3 of 3

Cleared Oct 21, 2016

Anesthesiology · 165d

Cleared Mar 06, 2015

PULMONE MINIBOXPFT 2.0

Anesthesiology · 247d

Cleared CT May 02, 2014

PULMONE MINIBOX PFT TM

Anesthesiology · 217d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 19, 2026