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FDA 510(k)

TCX-I REMOTE CARE MANAGEMENT SYSTEM

K-Number: K113493 · 2011-12-21

ApplicantBl Healthcare, Inc.
Decision Date2011-12-21
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TCX-I REMOTE CARE MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bl Healthcare, Inc.. It received FDA 510(k) clearance on 2011-12-21 under 510(k) number K113493. 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 TCX-I REMOTE CARE MANAGEMENT SYSTEM?

TCX-I REMOTE CARE MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2011-12-21. The listed applicant is Bl Healthcare, Inc.. The 510(k) number is K113493.

When did TCX-I REMOTE CARE MANAGEMENT SYSTEM receive FDA 510(k) clearance?

TCX-I REMOTE CARE MANAGEMENT SYSTEM received FDA 510(k) clearance on 2011-12-21, under 510(k) number K113493.

Who is the listed applicant for TCX-I REMOTE CARE MANAGEMENT SYSTEM?

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

What is the FDA product code for TCX-I REMOTE CARE MANAGEMENT SYSTEM?

The FDA product code for TCX-I REMOTE CARE MANAGEMENT SYSTEM 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.

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Other records listing Bl Healthcare, 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.

K101078BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEMK093379TCX-I-DV REMOTE CARE MANAGEMENT SYSTEMK052608TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS)K051470REMOTE CARE MANAGEMENT SYSTEMS (RCMS)

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

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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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