FDA 510(k)

Fusion Bx 2.0

K-Number: K181290 · 2018-06-15

Decision Date2018-06-15

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Fusion Bx 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Focal Healthcare, Inc.. It received FDA 510(k) clearance on 2018-06-15 under 510(k) number K181290. 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 Fusion Bx 2.0?

Fusion Bx 2.0 is a medical device that received FDA 510(k) clearance on 2018-06-15. The listed applicant is Focal Healthcare, Inc.. The 510(k) number is K181290.

When did Fusion Bx 2.0 receive FDA 510(k) clearance?

Fusion Bx 2.0 received FDA 510(k) clearance on 2018-06-15, under 510(k) number K181290.

Who is the listed applicant for Fusion Bx 2.0?

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

What is the FDA product code for Fusion Bx 2.0?

The FDA product code for Fusion Bx 2.0 is LLZ.

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.