HIVOX DREAMATE DM-800— 510(k) K021952

Substantially Equivalent

Hivox Biotek, Inc.

FDA 510(k) clearance K021952 for HIVOX DREAMATE DM-800, Substantially Equivalent on 2003-05-02. Applicant: Hivox Biotek, Inc.. Device class: 2.

Clearance details

Applicant: Hivox Biotek, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2002-06-13
Decision date: 2003-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin-Chu City, TW

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.