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FDA 510(k)

Fusion Bx 2.0

K-Number: K181290 · 2018-06-15

ApplicantFocal Healthcare, Inc.
Decision Date2018-06-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Fusion Bx 2.0 is a medical device manufactured by Focal Healthcare, Inc.. It received FDA 510(k) clearance on 2018-06-15 under approval 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. It is manufactured by Focal Healthcare, Inc.. The 510(k) number is K181290.

When was Fusion Bx 2.0 approved by the FDA?

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

What company makes Fusion Bx 2.0?

Fusion Bx 2.0 is manufactured by Focal Healthcare, Inc..

What is the FDA product code for Fusion Bx 2.0?

The FDA product code for Fusion Bx 2.0 is LLZ.

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Official Source

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