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FDA 510(k)

BTL-094

K-Number: K221865 · 2023-04-14

ApplicantBTL Industries, Inc.
Decision Date2023-04-14
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BTL-094 is a medical device manufactured by BTL Industries, Inc.. It received FDA 510(k) clearance on 2023-04-14 under approval number K221865. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BTL-094?

BTL-094 is a medical device that received FDA 510(k) clearance on 2023-04-14. It is manufactured by BTL Industries, Inc.. The 510(k) number is K221865.

When was BTL-094 approved by the FDA?

BTL-094 received FDA 510(k) clearance on 2023-04-14, under approval number K221865.

What company makes BTL-094?

BTL-094 is manufactured by BTL Industries, Inc..

What is the FDA product code for BTL-094?

The FDA product code for BTL-094 is ISA.

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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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