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FDA 510(k)

IMDX VANR FOR ABBOTT M2000

K-Number: K123753 · 2013-07-17

ApplicantIntelligent Medical Devices, Inc.
Decision Date2013-07-17
Product CodeNIJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMDX VANR FOR ABBOTT M2000 is the device name listed in this FDA 510(k) record. The listed applicant is Intelligent Medical Devices, Inc.. It received FDA 510(k) clearance on 2013-07-17 under 510(k) number K123753. The device is classified under product code NIJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMDX VANR FOR ABBOTT M2000?

IMDX VANR FOR ABBOTT M2000 is a medical device that received FDA 510(k) clearance on 2013-07-17. The listed applicant is Intelligent Medical Devices, Inc.. The 510(k) number is K123753.

When did IMDX VANR FOR ABBOTT M2000 receive FDA 510(k) clearance?

IMDX VANR FOR ABBOTT M2000 received FDA 510(k) clearance on 2013-07-17, under 510(k) number K123753.

Who is the listed applicant for IMDX VANR FOR ABBOTT M2000?

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

What is the FDA product code for IMDX VANR FOR ABBOTT M2000?

The FDA product code for IMDX VANR FOR ABBOTT M2000 is NIJ.

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 Intelligent Medical Devices, 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.

K132235IMDX C.DIFFICILE FOR ABBOTT M2000K131584IMDX FLU A/B AND RSV FOR ABBOTT M2000

Related Devices (Code: NIJ)

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.

K243405Xpert vanACepheid®K102416BD GENEOHM VANR ASSAYBd Diagnostics ScienceK092953Xpert VanA AssayCepheidK061686IDI-VANR ASSAYGeneohm Sciences Canada, Inc.K020576VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VREId Biomedical Corp.

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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