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FDA 510(k)

ELIXBO PM545

K-Number: K130658 · 2013-07-19

ApplicantXbo Medical Systems Co., Ltd.
Decision Date2013-07-19
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ELIXBO PM545 is the device name listed in this FDA 510(k) record. The listed applicant is Xbo Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2013-07-19 under 510(k) number K130658. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELIXBO PM545?

ELIXBO PM545 is a medical device that received FDA 510(k) clearance on 2013-07-19. The listed applicant is Xbo Medical Systems Co., Ltd.. The 510(k) number is K130658.

When did ELIXBO PM545 receive FDA 510(k) clearance?

ELIXBO PM545 received FDA 510(k) clearance on 2013-07-19, under 510(k) number K130658.

Who is the listed applicant for ELIXBO PM545?

The FDA 510(k) record lists Xbo Medical Systems Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELIXBO PM545?

The FDA product code for ELIXBO PM545 is LNH.

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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.

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