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FDA 510(k)

BTL-785BNF Handpiece

K-Number: K232172 · 2023-09-18

Decision Date2023-09-18
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BTL-785BNF Handpiece is a medical device manufactured by BTL Industries, Inc.. It received FDA 510(k) clearance on 2023-09-18 under approval number K232172. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BTL-785BNF Handpiece?

BTL-785BNF Handpiece is a medical device that received FDA 510(k) clearance on 2023-09-18. It is manufactured by BTL Industries, Inc.. The 510(k) number is K232172.

When was BTL-785BNF Handpiece approved by the FDA?

BTL-785BNF Handpiece received FDA 510(k) clearance on 2023-09-18, under approval number K232172.

What company makes BTL-785BNF Handpiece?

BTL-785BNF Handpiece is manufactured by BTL Industries, Inc..

What is the FDA product code for BTL-785BNF Handpiece?

The FDA product code for BTL-785BNF Handpiece is NFO.

Other Devices by BTL Industries, Inc.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.