FDA 510(k)

Spacelabs Lifescreen PRO Analyzer

K-Number: K201921 · 2021-03-26

Decision Date2021-03-26

Product CodeDQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Spacelabs Lifescreen PRO Analyzer is a medical device manufactured by Spacelabs Healthcare, Ltd.. It received FDA 510(k) clearance on 2021-03-26 under approval number K201921. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spacelabs Lifescreen PRO Analyzer?

Spacelabs Lifescreen PRO Analyzer is a medical device that received FDA 510(k) clearance on 2021-03-26. It is manufactured by Spacelabs Healthcare, Ltd.. The 510(k) number is K201921.

When was Spacelabs Lifescreen PRO Analyzer approved by the FDA?

Spacelabs Lifescreen PRO Analyzer received FDA 510(k) clearance on 2021-03-26, under approval number K201921.

What company makes Spacelabs Lifescreen PRO Analyzer?

Spacelabs Lifescreen PRO Analyzer is manufactured by Spacelabs Healthcare, Ltd..

What is the FDA product code for Spacelabs Lifescreen PRO Analyzer?

The FDA product code for Spacelabs Lifescreen PRO Analyzer is DQK.

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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.