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FDA 510(k)

BTL-995-rTMS

K-Number: K212723 · 2022-03-04

ApplicantBTL Industries, Inc.
Decision Date2022-03-04
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BTL-995-rTMS is a medical device manufactured by BTL Industries, Inc.. It received FDA 510(k) clearance on 2022-03-04 under approval number K212723. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BTL-995-rTMS?

BTL-995-rTMS is a medical device that received FDA 510(k) clearance on 2022-03-04. It is manufactured by BTL Industries, Inc.. The 510(k) number is K212723.

When was BTL-995-rTMS approved by the FDA?

BTL-995-rTMS received FDA 510(k) clearance on 2022-03-04, under approval number K212723.

What company makes BTL-995-rTMS?

BTL-995-rTMS is manufactured by BTL Industries, Inc..

What is the FDA product code for BTL-995-rTMS?

The FDA product code for BTL-995-rTMS is OBP.

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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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