MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM— 510(k) K962157

Name: FDA 510(k) clearance K962157
Creator: U.S. Food and Drug Administration
Published: 1996-11-25

Substantially Equivalent

Physiometrix, Inc.

FDA 510(k) clearance K962157 for MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM, Substantially Equivalent on 1996-11-25. 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: 1996-06-04
Decision date: 1996-11-25
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.