Medical Device Manufacturer · NZ , Auckland

Brainz Instruments , Ltd. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2003

Recent clearances: BRM3 BRAIN MONITOR, BRM2 BRAIN MONITOR, BRM2 BRAIN MONITOR

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Brainz Instruments , Ltd. Neurology ✕

3 devices

1-3 of 3

Cleared Sep 14, 2007

BRM3 BRAIN MONITOR

Neurology · 113d

Cleared Oct 10, 2003

BRM2 BRAIN MONITOR

Neurology · 14d

Cleared May 02, 2003

BRM2 BRAIN MONITOR

Neurology · 77d

Data Source

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

Last updated: Sep 29, 2026