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FDA 510(k)

BTL-899ST

K-Number: K202199 · 2021-01-26

ApplicantBtl
Decision Date2021-01-26
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BTL-899ST is a medical device manufactured by Btl. It received FDA 510(k) clearance on 2021-01-26 under approval number K202199. 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-899ST?

BTL-899ST is a medical device that received FDA 510(k) clearance on 2021-01-26. It is manufactured by Btl. The 510(k) number is K202199.

When was BTL-899ST approved by the FDA?

BTL-899ST received FDA 510(k) clearance on 2021-01-26, under approval number K202199.

What company makes BTL-899ST?

BTL-899ST is manufactured by Btl.

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

The FDA product code for BTL-899ST is GEI.

Other Devices by Btl

Related Devices (Code: GEI)

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.