MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM— 510(k) K970942

Name: FDA 510(k) clearance K970942
Creator: U.S. Food and Drug Administration
Published: 1997-06-02

Substantially Equivalent

Physiometrix, Inc.

FDA 510(k) clearance K970942 for MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM, Substantially Equivalent on 1997-06-02. Applicant: Physiometrix, Inc.. Device class: 2.

Clearance details

Applicant: Physiometrix, Inc.
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1997-03-14
Decision date: 1997-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Billerica, MA, 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.