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FDA 510(k)

D-CARIE, MODEL N121-M1

K-Number: K043156 · 2005-04-28

ApplicantNeks Technologies, Inc.
Decision Date2005-04-28
Product CodeNBL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

D-CARIE, MODEL N121-M1 is the device name listed in this FDA 510(k) record. The listed applicant is Neks Technologies, Inc.. It received FDA 510(k) clearance on 2005-04-28 under 510(k) number K043156. The device is classified under product code NBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the D-CARIE, MODEL N121-M1?

D-CARIE, MODEL N121-M1 is a medical device that received FDA 510(k) clearance on 2005-04-28. The listed applicant is Neks Technologies, Inc.. The 510(k) number is K043156.

When did D-CARIE, MODEL N121-M1 receive FDA 510(k) clearance?

D-CARIE, MODEL N121-M1 received FDA 510(k) clearance on 2005-04-28, under 510(k) number K043156.

Who is the listed applicant for D-CARIE, MODEL N121-M1?

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

What is the FDA product code for D-CARIE, MODEL N121-M1?

The FDA product code for D-CARIE, MODEL N121-M1 is NBL.

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 Neks Technologies, 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.

K063321D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138

Related Devices (Code: NBL)

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.

K252464Surgical Microscope (OMS2360, OMS2380)Zumax Medical Co., Ltd.K242103TRIOS Ready Tip3Shape TRIOS A/SK221275Qraycam PROAIOBIO Co., Ltd.K231722SmarToothSmartooth Co., Ltd.K223470C50SoproK221249L1P-1F (TRIOS 5)3Shape TRIOS A/S

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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