HEALTHDYNE'S EVENT RECORDER SYSTEM— 510(k) K860254

Name: FDA 510(k) clearance K860254
Creator: U.S. Food and Drug Administration
Published: 1986-01-30

Substantially Equivalent

Healthdyne, Inc.

FDA 510(k) clearance K860254 for HEALTHDYNE'S EVENT RECORDER SYSTEM, Substantially Equivalent on 1986-01-30. Applicant: Healthdyne, Inc.. Device class: 2.

Clearance details

Applicant: Healthdyne, Inc.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 1986-01-24
Decision date: 1986-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

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