510(k) K030489— BRM2 BRAIN MONITOR

Substantially Equivalent

Brainz Instruments , Ltd.

Clearance details

Applicant: Brainz Instruments , Ltd.
Product code: Code OLT
Advisory panel: Neurology
Date received: 2003-02-14
Decision date: 2003-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auckland, NZ

Adverse events under product code OLT

product code OLT

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.