FDA 510(k)

Xeleris V Processing and Review Systems

K-Number: K201103 · 2020-09-25

Decision Date2020-09-25

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Xeleris V Processing and Review Systems is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2020-09-25 under 510(k) 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. The listed applicant is GE Healthcare. The 510(k) number is K201103.

When did Xeleris V Processing and Review Systems receive FDA 510(k) clearance?

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

Who is the listed applicant for Xeleris V Processing and Review Systems?

The FDA 510(k) record lists GE Healthcare as the applicant. This does not by itself establish the device manufacturer.

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.