MECTA Sigma— 510(k) K192834

Substantially Equivalent

Mecta Corporation

FDA 510(k) clearance K192834 for MECTA Sigma, Substantially Equivalent on 2020-04-26. Applicant: Mecta Corporation. Device class: 2.

Clearance details

Applicant: Mecta Corporation
Product code: Code QGH
Device class: Class 2
Regulation: 21 CFR 882.5940
Advisory panel: Neurology
Date received: 2019-10-02
Decision date: 2020-04-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Suite B, OR, US

Download summary PDF View on FDA.gov ↗

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K911144 — MF-500, MODIFICATION1991-10-18
K863815 — ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-10001987-06-02

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