LIFELINES TRACKIT— 510(k) K010460

Substantially Equivalent

Lifelines , Ltd.

FDA 510(k) clearance K010460 for LIFELINES TRACKIT, Substantially Equivalent on 2001-05-14. Applicant: Lifelines , Ltd.. Device class: 2.

Clearance details

Applicant: Lifelines , Ltd.
Product code: Code OLV
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2001-02-16
Decision date: 2001-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, 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.