Cleared Special

Caretaker Platform, VitalStream Platform, CT5

K211588 · Caretaker Medical · Cardiovascular
Aug 2021
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K211588 is an FDA 510(k) clearance for the Caretaker Platform, VitalStream Platform, CT5, a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Caretaker Medical (Charlottesville, US). The FDA issued a Cleared decision on August 13, 2021, 81 days after receiving the submission on May 24, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K211588 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2021
Decision Date August 13, 2021
Days to Decision 81 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXN — System, Measurement, Blood-pressure, Non-invasive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1130

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