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FDA 510(k)

Caretaker Remote Display App and Caretaker Software Library

K-Number: K181196 · 2018-10-03

ApplicantCaretaker Medical, LLC
Decision Date2018-10-03
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Caretaker Remote Display App and Caretaker Software Library is a medical device manufactured by Caretaker Medical, LLC. It received FDA 510(k) clearance on 2018-10-03 under approval number K181196. 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 Caretaker Remote Display App and Caretaker Software Library?

Caretaker Remote Display App and Caretaker Software Library is a medical device that received FDA 510(k) clearance on 2018-10-03. It is manufactured by Caretaker Medical, LLC. The 510(k) number is K181196.

When was Caretaker Remote Display App and Caretaker Software Library approved by the FDA?

Caretaker Remote Display App and Caretaker Software Library received FDA 510(k) clearance on 2018-10-03, under approval number K181196.

What company makes Caretaker Remote Display App and Caretaker Software Library?

Caretaker Remote Display App and Caretaker Software Library is manufactured by Caretaker Medical, LLC.

What is the FDA product code for Caretaker Remote Display App and Caretaker Software Library?

The FDA product code for Caretaker Remote Display App and Caretaker Software Library is DRG.

Related Clinical Trials

NCT07557147 Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor NOT_YET_RECRUITING NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer NOT_YET_RECRUITING NCT06052891 CHAMP For the Feeder: Tube Feeding Study ENROLLING_BY_INVITATION NCT07231653 Home Monitoring Study for Surgical Patients NOT_YET_RECRUITING NCT07384741 Using Virtual Reality During PICC and PICC-PORT Placement in Cancer Patients ACTIVE_NOT_RECRUITING NCT04969757 Use of Predigraft in Kidney Transplant Patients COMPLETED

Related PubMed Literature

PMID: 40947420 Software as Medical Devices: requirements and regulatory landscape in the United States. Expert review of medical devices (2025)

Other Devices by Caretaker Medical, LLC

K151499CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor K213699CareTaker Monitor App

Related Devices (Code: DRG)

K161916TelePatch Cardiac MonitorMedicomp, Inc. K153719LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStreamHoneywell Hommed, LLC K163694Rooti Rx ECG Event Recorder, Rooti Link APP SoftwareRooti Labs , Ltd. K163453VitalPatch® VitalConnect PlatformVitalconnect, Inc. K171406Optum TeleHealth ApplicationUnited Health Group, Inc. K171029eCareCoordinatorVisicu, 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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