HR/BVP 100T HEART RATE MONITOR— 510(k) K850643

Name: FDA 510(k) clearance K850643
Creator: U.S. Food and Drug Administration
Published: 1985-05-17

Substantially Equivalent

Thought Technology , Ltd.

FDA 510(k) clearance K850643 for HR/BVP 100T HEART RATE MONITOR, Substantially Equivalent on 1985-05-17. Applicant: Thought Technology , Ltd.. Device class: 2.

Clearance details

Applicant: Thought Technology , Ltd.
Product code: Code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 1985-02-19
Decision date: 1985-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, Quebec, CA

Download summary PDF View on FDA.gov ↗

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