MEDI-DX 7000— 510(k) K964622

Substantially Equivalent

Neuro-Diagnostic Assoc.

FDA 510(k) clearance K964622 for MEDI-DX 7000, Substantially Equivalent on 1997-12-01. Applicant: Neuro-Diagnostic Assoc.. Device class: 1.

Clearance details

Applicant: Neuro-Diagnostic Assoc.
Product code: Code LLN
Device class: Class 1
Regulation: 21 CFR 882.1200
Advisory panel: Neurology
Date received: 1996-11-18
Decision date: 1997-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Beach, CA, US

Download summary PDF View on FDA.gov ↗

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