HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM— 510(k) K893094

Name: FDA 510(k) clearance K893094
Creator: U.S. Food and Drug Administration
Published: 1989-10-02

Substantially Equivalent

Heartware Intl. Corp.

FDA 510(k) clearance K893094 for HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM, Substantially Equivalent on 1989-10-02. Applicant: Heartware Intl. Corp.. Device class: 2.

Clearance details

Applicant: Heartware Intl. Corp.
Product code: Code JOQ
Device class: Class 2
Regulation: 21 CFR 870.1750
Advisory panel: Cardiovascular
Date received: 1989-04-28
Decision date: 1989-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, 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.