Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION

K-Number: K130360 · 2013-07-15

ApplicantConstant Care, LLC
Decision Date2013-07-15
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION is the device name listed in this FDA 510(k) record. The listed applicant is Constant Care, LLC. It received FDA 510(k) clearance on 2013-07-15 under 510(k) number K130360. 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 CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION?

CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION is a medical device that received FDA 510(k) clearance on 2013-07-15. The listed applicant is Constant Care, LLC. The 510(k) number is K130360.

When did CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION receive FDA 510(k) clearance?

CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION received FDA 510(k) clearance on 2013-07-15, under 510(k) number K130360.

Who is the listed applicant for CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION?

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

What is the FDA product code for CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION?

The FDA product code for CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION 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 Constant Care, LLC 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.

K120941CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM

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.

↑