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FDA 510(k)

Sparrow Therapy System

K-Number: K201873 · 2021-01-02

Decision Date2021-01-02
Product CodePZR
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Sparrow Therapy System is a medical device manufactured by Spark Biomedical, Inc.. It received FDA 510(k) clearance on 2021-01-02 under approval number K201873. The device is classified under product code PZR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sparrow Therapy System?

Sparrow Therapy System is a medical device that received FDA 510(k) clearance on 2021-01-02. It is manufactured by Spark Biomedical, Inc.. The 510(k) number is K201873.

When was Sparrow Therapy System approved by the FDA?

Sparrow Therapy System received FDA 510(k) clearance on 2021-01-02, under approval number K201873.

What company makes Sparrow Therapy System?

Sparrow Therapy System is manufactured by Spark Biomedical, Inc..

What is the FDA product code for Sparrow Therapy System?

The FDA product code for Sparrow Therapy System is PZR.

Related Clinical Trials

Related PubMed Literature

Other Devices by Spark Biomedical, Inc.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.