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FDA 510(k)

DETECTAR, MODEL N123-MI

K-Number: K023367 · 2003-06-25

ApplicantNeks Technologies
Decision Date2003-06-25
Product CodeEJB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DETECTAR, MODEL N123-MI is the device name listed in this FDA 510(k) record. The listed applicant is Neks Technologies. It received FDA 510(k) clearance on 2003-06-25 under 510(k) number K023367. The device is classified under product code EJB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DETECTAR, MODEL N123-MI?

DETECTAR, MODEL N123-MI is a medical device that received FDA 510(k) clearance on 2003-06-25. The listed applicant is Neks Technologies. The 510(k) number is K023367.

When did DETECTAR, MODEL N123-MI receive FDA 510(k) clearance?

DETECTAR, MODEL N123-MI received FDA 510(k) clearance on 2003-06-25, under 510(k) number K023367.

Who is the listed applicant for DETECTAR, MODEL N123-MI?

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

What is the FDA product code for DETECTAR, MODEL N123-MI?

The FDA product code for DETECTAR, MODEL N123-MI is EJB.

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Related Devices (Code: EJB)

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.

K981234FLARE,FILE, FILLLone Star TechnologiesK930094AUKUSLEEVEAukland Medical Plastics, Inc.K922633CAVI-ZYMEE&D Dental Products, Inc.K871818SPATULA, DENTAL, CEMENTMilitary Engineering, Inc.K833338TOOTH SLOOTHJoel Lander D.D.S.K823913SOFT GRIP UNI-HANDLETreace Medical, Inc.

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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