EPS320 CARDIAC STIMULATOR— 510(k) K011826

Substantially Equivalent

Micropace Pty, Ltd.

FDA 510(k) clearance K011826 for EPS320 CARDIAC STIMULATOR, Substantially Equivalent on 2002-01-24. Applicant: Micropace Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Micropace Pty, Ltd.
Product code: Code JOQ
Device class: Class 2
Regulation: 21 CFR 870.1750
Advisory panel: Cardiovascular
Date received: 2001-06-11
Decision date: 2002-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Campsie, N.S.W., AU

Download summary PDF View on FDA.gov ↗

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