Orion LifeSpan MEG— 510(k) K191785

Substantially Equivalent

Compumedics Limited

FDA 510(k) clearance K191785 for Orion LifeSpan MEG, Substantially Equivalent on 2020-02-14. Applicant: Compumedics Limited. Device class: 2.

Clearance details

Applicant: Compumedics Limited
Product code: Code OLY
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2019-07-03
Decision date: 2020-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbotsford, AU

Download summary PDF View on FDA.gov ↗

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K962764 — NEUROMAG-1221996-10-31
K854466 — BIOMAGNETIC TECHNOLOGIES NEUROMAGNEOMETER1986-02-04

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