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FDA 510(k)

CONFIDANT 2.0

K-Number: K062215 · 2006-10-16

ApplicantConfidant, Inc.
Decision Date2006-10-16
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CONFIDANT 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Confidant, Inc.. It received FDA 510(k) clearance on 2006-10-16 under 510(k) number K062215. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONFIDANT 2.0?

CONFIDANT 2.0 is a medical device that received FDA 510(k) clearance on 2006-10-16. The listed applicant is Confidant, Inc.. The 510(k) number is K062215.

When did CONFIDANT 2.0 receive FDA 510(k) clearance?

CONFIDANT 2.0 received FDA 510(k) clearance on 2006-10-16, under 510(k) number K062215.

Who is the listed applicant for CONFIDANT 2.0?

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

What is the FDA product code for CONFIDANT 2.0?

The FDA product code for CONFIDANT 2.0 is DRG.

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 Confidant, 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.

K083331CONFIDANT, MODEL 2.6K072698CONFIDANT 2.5

Related Devices (Code: DRG)

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.

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.

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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