NEUROMETRICS MONITOR— 510(k) K800452

Substantially Equivalent

Neurometrics

FDA 510(k) clearance K800452 for NEUROMETRICS MONITOR, Substantially Equivalent on 1980-04-02. Applicant: Neurometrics. Device class: 1.

Clearance details

Applicant: Neurometrics
Product code: Code GWS
Device class: Class 1
Regulation: 21 CFR 882.1420
Advisory panel: Neurology
Date received: 1980-02-28
Decision date: 1980-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code GWS

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K894629 — NICOLET BEAM II SYSTEM1990-03-09
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More clearances from Neurometrics

K861900 — LIFESCAN EVOKED POTENTIAL SYSTEM1986-08-25
K841790 — LIFESCAN EEG MONITOR1984-07-12

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