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FDA 510(k)

BTL-899 FP

K-Number: K211107 · 2021-07-09

ApplicantBTL Industries, Inc.
Decision Date2021-07-09
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BTL-899 FP is a medical device manufactured by BTL Industries, Inc.. It received FDA 510(k) clearance on 2021-07-09 under approval number K211107. 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-899 FP?

BTL-899 FP is a medical device that received FDA 510(k) clearance on 2021-07-09. It is manufactured by BTL Industries, Inc.. The 510(k) number is K211107.

When was BTL-899 FP approved by the FDA?

BTL-899 FP received FDA 510(k) clearance on 2021-07-09, under approval number K211107.

What company makes BTL-899 FP?

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

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

The FDA product code for BTL-899 FP 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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