MODEL 16800 TREND RECORDER— 510(k) K821612

Substantially Equivalent

Healthdyne, Inc.

FDA 510(k) clearance K821612 for MODEL 16800 TREND RECORDER, Substantially Equivalent on 1982-07-14. Applicant: Healthdyne, Inc.. Device class: 1.

Clearance details

Applicant: Healthdyne, Inc.
Product code: Code DSF
Device class: Class 1
Regulation: 21 CFR 870.2810
Advisory panel: Cardiovascular
Date received: 1982-06-02
Decision date: 1982-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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