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FDA 510(k)

BTL-899F

K-Number: K230467 · 2023-09-21

ApplicantBTL Industries, Inc.
Decision Date2023-09-21
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BTL-899F is a medical device manufactured by BTL Industries, Inc.. It received FDA 510(k) clearance on 2023-09-21 under approval number K230467. 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-899F?

BTL-899F is a medical device that received FDA 510(k) clearance on 2023-09-21. It is manufactured by BTL Industries, Inc.. The 510(k) number is K230467.

When was BTL-899F approved by the FDA?

BTL-899F received FDA 510(k) clearance on 2023-09-21, under approval number K230467.

What company makes BTL-899F?

BTL-899F is manufactured by BTL Industries, Inc..

What is the FDA product code for BTL-899F?

The FDA product code for BTL-899F 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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