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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 the device name listed in this FDA 510(k) record. The listed applicant is Caretaker Medical, LLC. It received FDA 510(k) clearance on 2018-10-03 under 510(k) 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. The listed applicant is Caretaker Medical, LLC. The 510(k) number is K181196.

When did Caretaker Remote Display App and Caretaker Software Library receive FDA 510(k) clearance?

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

Who is the listed applicant for Caretaker Remote Display App and Caretaker Software Library?

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

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.

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Other records listing Caretaker Medical, 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.

K251275VitalStream ART Connect; VitalStream-HemoK213699CareTaker Monitor AppK211588Caretaker Platform, VitalStream Platform, CT5K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological MonitorK151499CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor

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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