GUIDELINE SYSTEM— 510(k) K970943

Substantially Equivalent

Axon Instruments, Inc.

FDA 510(k) clearance K970943 for GUIDELINE SYSTEM, Substantially Equivalent on 1997-08-18. Applicant: Axon Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Axon Instruments, Inc.
Product code: Code GZL
Device class: Class 2
Regulation: 21 CFR 882.1330
Advisory panel: Neurology
Date received: 1997-03-14
Decision date: 1997-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foster City, CA, US

Download summary PDF View on FDA.gov ↗

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