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FDA 510(k)

BTL 799-2T

K-Number: K182106 · 2018-10-23

Decision Date2018-10-23
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BTL 799-2T 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 2018-10-23 under 510(k) number K182106. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BTL 799-2T?

BTL 799-2T is a medical device that received FDA 510(k) clearance on 2018-10-23. The listed applicant is BTL Industries, Inc.. The 510(k) number is K182106.

When did BTL 799-2T receive FDA 510(k) clearance?

BTL 799-2T received FDA 510(k) clearance on 2018-10-23, under 510(k) number K182106.

Who is the listed applicant for BTL 799-2T?

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 799-2T?

The FDA product code for BTL 799-2T is NGX.

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: NGX)

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

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