ZMACHINE, MODEL DT-100— 510(k) K101830

Name: FDA 510(k) clearance K101830
Creator: U.S. Food and Drug Administration
Published: 2011-03-31

Substantially Equivalent

Consolidated Research of Richmond, Inc.

FDA 510(k) clearance K101830 for ZMACHINE, MODEL DT-100, Substantially Equivalent on 2011-03-31. Applicant: Consolidated Research of Richmond, Inc.. Device class: 2.

Clearance details

Applicant: Consolidated Research of Richmond, Inc.
Product code: Code OLV
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2010-07-01
Decision date: 2011-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Euclid, OH, US

Download summary PDF View on FDA.gov ↗

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