BTL-785MJ
K-Number: K243290 · 2025-05-09
ApplicantBTL Industries, Inc.
Decision Date2025-05-09
Product CodeNUW
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
BTL-785MJ is a medical device manufactured by BTL Industries, Inc.. It received FDA 510(k) clearance on 2025-05-09 under approval number K243290. The device is classified under product code NUW. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BTL-785MJ?
BTL-785MJ is a medical device that received FDA 510(k) clearance on 2025-05-09. It is manufactured by BTL Industries, Inc.. The 510(k) number is K243290.
When was BTL-785MJ approved by the FDA?
BTL-785MJ received FDA 510(k) clearance on 2025-05-09, under approval number K243290.
What company makes BTL-785MJ?
BTL-785MJ is manufactured by BTL Industries, Inc..
What is the FDA product code for BTL-785MJ?
The FDA product code for BTL-785MJ is NUW.
Other Devices by BTL Industries, Inc.
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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.