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FDA 510(k)

BTL-899MS

K-Number: K240234 · 2024-08-17

Decision Date2024-08-17
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BTL-899MS 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 2024-08-17 under 510(k) number K240234. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BTL-899MS?

BTL-899MS is a medical device that received FDA 510(k) clearance on 2024-08-17. The listed applicant is BTL Industries, Inc.. The 510(k) number is K240234.

When did BTL-899MS receive FDA 510(k) clearance?

BTL-899MS received FDA 510(k) clearance on 2024-08-17, under 510(k) number K240234.

Who is the listed applicant for BTL-899MS?

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-899MS?

The FDA product code for BTL-899MS is IPF.

Related Clinical Trials

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.

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.

View all 34 devices →

Related Devices (Code: IPF)

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.

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.