ALICE— 510(k) K922106

Substantially Equivalent

Healthdyne, Inc.

FDA 510(k) clearance K922106 for ALICE, Substantially Equivalent on 1994-07-06. Applicant: Healthdyne, Inc.. Device class: 2.

Clearance details

Applicant: Healthdyne, Inc.
Product code: Code OLV
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1992-05-05
Decision date: 1994-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, 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.