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FDA 510(k)

BTL-FR2000

K-Number: K180359 · 2018-12-13

ApplicantBTL Industries, Inc.
Decision Date2018-12-13
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BTL-FR2000 is a medical device manufactured by BTL Industries, Inc.. It received FDA 510(k) clearance on 2018-12-13 under approval number K180359. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BTL-FR2000?

BTL-FR2000 is a medical device that received FDA 510(k) clearance on 2018-12-13. It is manufactured by BTL Industries, Inc.. The 510(k) number is K180359.

When was BTL-FR2000 approved by the FDA?

BTL-FR2000 received FDA 510(k) clearance on 2018-12-13, under approval number K180359.

What company makes BTL-FR2000?

BTL-FR2000 is manufactured by BTL Industries, Inc..

What is the FDA product code for BTL-FR2000?

The FDA product code for BTL-FR2000 is GEI.

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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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