PACE-1A CARDIAC STIMULATOR— 510(k) K963579

Substantially Equivalent

Radionics, Inc.

FDA 510(k) clearance K963579 for PACE-1A CARDIAC STIMULATOR, Substantially Equivalent on 1996-11-08. Applicant: Radionics, Inc.. Device class: 2.

Clearance details

Applicant: Radionics, Inc.
Product code: Code JOQ
Device class: Class 2
Regulation: 21 CFR 870.1750
Advisory panel: Cardiovascular
Date received: 1996-09-06
Decision date: 1996-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, 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.