Sparrow Therapy System— 510(k) K201873

Substantially Equivalent

Spark Biomedical, Inc.

FDA 510(k) clearance K201873 for Sparrow Therapy System, Substantially Equivalent on 2021-01-02. Applicant: Spark Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Spark Biomedical, Inc.
Product code: Code PZR
Device class: Class 2
Regulation: 21 CFR 882.5896
Advisory panel: Neurology
Date received: 2020-07-07
Decision date: 2021-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, 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.