FLOW SPIROMETER— 510(k) K934502

Substantially Equivalent

Healthdyne, Inc.

FDA 510(k) clearance K934502 for FLOW SPIROMETER, Substantially Equivalent on 1994-04-04. Applicant: Healthdyne, Inc.. Device class: 2.

Clearance details

Applicant: Healthdyne, Inc.
Product code: Code BZH
Device class: Class 2
Regulation: 21 CFR 868.1860
Advisory panel: Anesthesiology
Date received: 1993-09-14
Decision date: 1994-04-04
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.