DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES— 510(k) K062996

Name: FDA 510(k) clearance K062996
Creator: U.S. Food and Drug Administration
Published: 2007-01-12

Substantially Equivalent

Axon Systems, Inc.

FDA 510(k) clearance K062996 for DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES, Substantially Equivalent on 2007-01-12. Applicant: Axon Systems, Inc.. Device class: 2.

Clearance details

Applicant: Axon Systems, Inc.
Product code: Code GXZ
Device class: Class 2
Regulation: 21 CFR 882.1350
Advisory panel: Neurology
Date received: 2006-10-02
Decision date: 2007-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hauppauge, NY, US

Download summary PDF View on FDA.gov ↗

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