ULTRA-CHEK PACEMAKER MONITOR— 510(k) K801022

Name: FDA 510(k) clearance K801022
Creator: U.S. Food and Drug Administration
Published: 1980-06-17

Substantially Equivalent

Powers Medical Systmes

FDA 510(k) clearance K801022 for ULTRA-CHEK PACEMAKER MONITOR, Substantially Equivalent on 1980-06-17. Applicant: Powers Medical Systmes. Device class: 2.

Clearance details

Applicant: Powers Medical Systmes
Product code: Code KRE
Device class: Class 2
Regulation: 21 CFR 870.3640
Advisory panel: Cardiovascular
Date received: 1980-04-30
Decision date: 1980-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.