PSA4000 EEG MONITOR WITH FRONTAL PSI— 510(k) K020671

Name: FDA 510(k) clearance K020671
Creator: U.S. Food and Drug Administration
Published: 2002-10-04

Substantially Equivalent

Physiometrix, Inc.

FDA 510(k) clearance K020671 for PSA4000 EEG MONITOR WITH FRONTAL PSI, Substantially Equivalent on 2002-10-04. Applicant: Physiometrix, Inc.. Device class: 2.

Clearance details

Applicant: Physiometrix, Inc.
Product code: Code OLW
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2002-03-01
Decision date: 2002-10-04
Decision: Substantially Equivalent
Clearance type: Special
Location: North Billerica, MA, US

Download summary PDF View on FDA.gov ↗

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