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FDA 510(k)

CareTaker Monitor App

K-Number: K213699 · 2022-03-30

ApplicantCaretaker Medical, LLC
Decision Date2022-03-30
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CareTaker Monitor App is a medical device manufactured by Caretaker Medical, LLC. It received FDA 510(k) clearance on 2022-03-30 under approval number K213699. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CareTaker Monitor App?

CareTaker Monitor App is a medical device that received FDA 510(k) clearance on 2022-03-30. It is manufactured by Caretaker Medical, LLC. The 510(k) number is K213699.

When was CareTaker Monitor App approved by the FDA?

CareTaker Monitor App received FDA 510(k) clearance on 2022-03-30, under approval number K213699.

What company makes CareTaker Monitor App?

CareTaker Monitor App is manufactured by Caretaker Medical, LLC.

What is the FDA product code for CareTaker Monitor App?

The FDA product code for CareTaker Monitor App is DXN.

Related Clinical Trials

NCT04817137 Validation of a Novel Non-invasive Continuous Blood Pressure Monitor in Children Ages 2- 17 Years-old COMPLETED

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 K181196Caretaker Remote Display App and Caretaker Software Library

Related Devices (Code: DXN)

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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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