ALICE 4R SYSTEM— 510(k) K971867

Substantially Equivalent

Healthdyne Technologies, Inc.

FDA 510(k) clearance K971867 for ALICE 4R SYSTEM, Substantially Equivalent on 1997-08-13. Applicant: Healthdyne Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Healthdyne Technologies, Inc.
Product code: Code OLV
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1997-05-20
Decision date: 1997-08-13
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.