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FDA 510(k)

BTL-785NEH

K-Number: K253750 · 2026-03-17

ApplicantBTL Industries, Inc.
Decision Date2026-03-17
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BTL-785NEH is a medical device manufactured by BTL Industries, Inc.. It received FDA 510(k) clearance on 2026-03-17 under approval number K253750. 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-785NEH?

BTL-785NEH is a medical device that received FDA 510(k) clearance on 2026-03-17. It is manufactured by BTL Industries, Inc.. The 510(k) number is K253750.

When was BTL-785NEH approved by the FDA?

BTL-785NEH received FDA 510(k) clearance on 2026-03-17, under approval number K253750.

What company makes BTL-785NEH?

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

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

The FDA product code for BTL-785NEH 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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