BRM3 BRAIN MONITOR— 510(k) K071449

Substantially Equivalent

Brainz Instruments , Ltd.

FDA 510(k) clearance K071449 for BRM3 BRAIN MONITOR, Substantially Equivalent on 2007-09-14. Applicant: Brainz Instruments , Ltd.. Device class: 2.

Clearance details

Applicant: Brainz Instruments , Ltd.
Product code: Code OMA
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2007-05-24
Decision date: 2007-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auckland, NZ

Download summary PDF View on FDA.gov ↗

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