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FDA 510(k)

CHECKPOINT

K-Number: K092292 · 2009-10-28

ApplicantNdi Medical, LLC
Decision Date2009-10-28
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CHECKPOINT is the device name listed in this FDA 510(k) record. The listed applicant is Ndi Medical, LLC. It received FDA 510(k) clearance on 2009-10-28 under 510(k) number K092292. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHECKPOINT?

CHECKPOINT is a medical device that received FDA 510(k) clearance on 2009-10-28. The listed applicant is Ndi Medical, LLC. The 510(k) number is K092292.

When did CHECKPOINT receive FDA 510(k) clearance?

CHECKPOINT received FDA 510(k) clearance on 2009-10-28, under 510(k) number K092292.

Who is the listed applicant for CHECKPOINT?

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

What is the FDA product code for CHECKPOINT?

The FDA product code for CHECKPOINT is ETN.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ndi Medical, 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.

K061365CHECKPOINT WITH ACCUSTIM TECHNOLOGY

Related Devices (Code: ETN)

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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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