NEUROCALM MODEL 1 AND 2— 510(k) K090866

Substantially Equivalent

Neuromed Devices, Inc.

FDA 510(k) clearance K090866 for NEUROCALM MODEL 1 AND 2, Substantially Equivalent on 2009-10-21. Applicant: Neuromed Devices, Inc.. Device class: 2.

Clearance details

Applicant: Neuromed Devices, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2009-03-31
Decision date: 2009-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Niguel, CA, US

Download summary PDF View on FDA.gov ↗

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