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FDA 510(k)

Xeleris V Processing and Review Systems

K-Number: K201103 · 2020-09-25

ApplicantGE Healthcare
Decision Date2020-09-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Xeleris V Processing and Review Systems is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2020-09-25 under approval number K201103. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xeleris V Processing and Review Systems?

Xeleris V Processing and Review Systems is a medical device that received FDA 510(k) clearance on 2020-09-25. It is manufactured by GE Healthcare. The 510(k) number is K201103.

When was Xeleris V Processing and Review Systems approved by the FDA?

Xeleris V Processing and Review Systems received FDA 510(k) clearance on 2020-09-25, under approval number K201103.

What company makes Xeleris V Processing and Review Systems?

Xeleris V Processing and Review Systems is manufactured by GE Healthcare.

What is the FDA product code for Xeleris V Processing and Review Systems?

The FDA product code for Xeleris V Processing and Review Systems is LLZ.

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Official Source

View on FDA Database →

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

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