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FDA 510(k)

BTL-785F

K-Number: K193201 · 2020-08-21

ApplicantBtl
Decision Date2020-08-21
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BTL-785F is a medical device manufactured by Btl. It received FDA 510(k) clearance on 2020-08-21 under approval number K193201. 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-785F?

BTL-785F is a medical device that received FDA 510(k) clearance on 2020-08-21. It is manufactured by Btl. The 510(k) number is K193201.

When was BTL-785F approved by the FDA?

BTL-785F received FDA 510(k) clearance on 2020-08-21, under approval number K193201.

What company makes BTL-785F?

BTL-785F is manufactured by Btl.

What is the FDA product code for BTL-785F?

The FDA product code for BTL-785F 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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