BLOOD GLUCOSE MONITOR— 510(k) K834099

Substantially Equivalent

Healthdyne, Inc.

FDA 510(k) clearance K834099 for BLOOD GLUCOSE MONITOR, Substantially Equivalent on 1984-02-03. Applicant: Healthdyne, Inc.. Device class: 1.

Clearance details

Applicant: Healthdyne, Inc.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1983-11-28
Decision date: 1984-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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