BRM2 BRAIN MONITOR— 510(k) K033010

Substantially Equivalent

Brainz Instruments , Ltd.

FDA 510(k) clearance K033010 for BRM2 BRAIN MONITOR, Substantially Equivalent on 2003-10-10. Applicant: Brainz Instruments , Ltd..

Clearance details

Applicant: Brainz Instruments , Ltd.
Product code: Code OLT
Advisory panel: Neurology
Date received: 2003-09-26
Decision date: 2003-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auckland, NZ

Download summary PDF View on FDA.gov ↗

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.