NEUROMAP— 510(k) K981820

Substantially Equivalent

Radionics, Inc.

FDA 510(k) clearance K981820 for NEUROMAP, Substantially Equivalent on 1998-11-20. Applicant: Radionics, Inc.. Device class: 2.

Clearance details

Applicant: Radionics, Inc.
Product code: Code GZL
Device class: Class 2
Regulation: 21 CFR 882.1330
Advisory panel: Neurology
Date received: 1998-05-22
Decision date: 1998-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, 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.