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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is BTL Industries, Inc.. It received FDA 510(k) clearance on 2025-05-09 under 510(k) 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. The listed applicant is BTL Industries, Inc.. The 510(k) number is K243290.

When did BTL-785MJ receive FDA 510(k) clearance?

BTL-785MJ received FDA 510(k) clearance on 2025-05-09, under 510(k) number K243290.

Who is the listed applicant for BTL-785MJ?

The FDA 510(k) record lists BTL Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BTL-785MJ?

The FDA product code for BTL-785MJ is NUW.

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Other records listing BTL Industries, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252963BTL-899TTK253750BTL-785NEHK252561BTL-754FFK250309BTL-199K241516BTL-398K241270BTL-754

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Related Devices (Code: NUW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203525D functionIto Co., Ltd.

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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