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FDA 510(k)

BTL-785X

K-Number: K222556 · 2023-05-31

ApplicantBTL Industries, Inc.
Decision Date2023-05-31
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BTL-785X is a medical device manufactured by BTL Industries, Inc.. It received FDA 510(k) clearance on 2023-05-31 under approval number K222556. 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-785X?

BTL-785X is a medical device that received FDA 510(k) clearance on 2023-05-31. It is manufactured by BTL Industries, Inc.. The 510(k) number is K222556.

When was BTL-785X approved by the FDA?

BTL-785X received FDA 510(k) clearance on 2023-05-31, under approval number K222556.

What company makes BTL-785X?

BTL-785X is manufactured by BTL Industries, Inc..

What is the FDA product code for BTL-785X?

The FDA product code for BTL-785X 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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