UNIQUE AMBULATORY EEG— 510(k) K010697

Substantially Equivalent

Axon Systems, Inc.

FDA 510(k) clearance K010697 for UNIQUE AMBULATORY EEG, Substantially Equivalent on 2001-06-06. Applicant: Axon Systems, Inc.. Device class: 2.

Clearance details

Applicant: Axon Systems, Inc.
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2001-03-08
Decision date: 2001-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hauppauge, NY, US

Download summary PDF View on FDA.gov ↗

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