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FDA 510(k)

TBL-ABI System

K-Number: K173696 · 2017-12-19

ApplicantLd Technology, LLC
Decision Date2017-12-19
Product CodeJOM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TBL-ABI System is the device name listed in this FDA 510(k) record. The listed applicant is Ld Technology, LLC. It received FDA 510(k) clearance on 2017-12-19 under 510(k) number K173696. The device is classified under product code JOM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TBL-ABI System?

TBL-ABI System is a medical device that received FDA 510(k) clearance on 2017-12-19. The listed applicant is Ld Technology, LLC. The 510(k) number is K173696.

When did TBL-ABI System receive FDA 510(k) clearance?

TBL-ABI System received FDA 510(k) clearance on 2017-12-19, under 510(k) number K173696.

Who is the listed applicant for TBL-ABI System?

The FDA 510(k) record lists Ld Technology, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TBL-ABI System?

The FDA product code for TBL-ABI System is JOM.

Other records listing Ld Technology, LLC 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.

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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.

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