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FDA 510(k)

BTL-785BNF-E

K-Number: K242532 · 2024-12-13

ApplicantBTL Industries, Inc.
Decision Date2024-12-13
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BTL-785BNF-E is a medical device manufactured by BTL Industries, Inc.. It received FDA 510(k) clearance on 2024-12-13 under approval number K242532. 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-E?

BTL-785BNF-E is a medical device that received FDA 510(k) clearance on 2024-12-13. It is manufactured by BTL Industries, Inc.. The 510(k) number is K242532.

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

BTL-785BNF-E received FDA 510(k) clearance on 2024-12-13, under approval number K242532.

What company makes BTL-785BNF-E?

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

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

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

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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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