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FDA 510(k)

BTL-199

K-Number: K250309 · 2025-08-07

ApplicantBTL Industries, Inc.
Decision Date2025-08-07
Product CodeQPL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BTL-199 is a medical device manufactured by BTL Industries, Inc.. It received FDA 510(k) clearance on 2025-08-07 under approval number K250309. The device is classified under product code QPL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BTL-199?

BTL-199 is a medical device that received FDA 510(k) clearance on 2025-08-07. It is manufactured by BTL Industries, Inc.. The 510(k) number is K250309.

When was BTL-199 approved by the FDA?

BTL-199 received FDA 510(k) clearance on 2025-08-07, under approval number K250309.

What company makes BTL-199?

BTL-199 is manufactured by BTL Industries, Inc..

What is the FDA product code for BTL-199?

The FDA product code for BTL-199 is QPL.

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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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