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FDA 510(k)

REMOTE CARE MANAGEMENT SYSTEMS (RCMS)

K-Number: K051470 · 2005-06-08

ApplicantBl Healthcare, Inc.
Decision Date2005-06-08
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REMOTE CARE MANAGEMENT SYSTEMS (RCMS) 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 2005-06-08 under 510(k) number K051470. 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 REMOTE CARE MANAGEMENT SYSTEMS (RCMS)?

REMOTE CARE MANAGEMENT SYSTEMS (RCMS) is a medical device that received FDA 510(k) clearance on 2005-06-08. The listed applicant is Bl Healthcare, Inc.. The 510(k) number is K051470.

When did REMOTE CARE MANAGEMENT SYSTEMS (RCMS) receive FDA 510(k) clearance?

REMOTE CARE MANAGEMENT SYSTEMS (RCMS) received FDA 510(k) clearance on 2005-06-08, under 510(k) number K051470.

Who is the listed applicant for REMOTE CARE MANAGEMENT SYSTEMS (RCMS)?

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 REMOTE CARE MANAGEMENT SYSTEMS (RCMS)?

The FDA product code for REMOTE CARE MANAGEMENT SYSTEMS (RCMS) 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 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.

K113493TCX-I REMOTE CARE MANAGEMENT SYSTEMK101078BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEMK093379TCX-I-DV REMOTE CARE MANAGEMENT SYSTEMK052608TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (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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