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FDA 510(k)

BTL-703-2

K-Number: K200382 · 2021-01-06

ApplicantBtl
Decision Date2021-01-06
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BTL-703-2 is a medical device manufactured by Btl. It received FDA 510(k) clearance on 2021-01-06 under approval number K200382. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BTL-703-2?

BTL-703-2 is a medical device that received FDA 510(k) clearance on 2021-01-06. It is manufactured by Btl. The 510(k) number is K200382.

When was BTL-703-2 approved by the FDA?

BTL-703-2 received FDA 510(k) clearance on 2021-01-06, under approval number K200382.

What company makes BTL-703-2?

BTL-703-2 is manufactured by Btl.

What is the FDA product code for BTL-703-2?

The FDA product code for BTL-703-2 is NGX.

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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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