Cleared Traditional

CONNEQT PULSE

K221742 · Atcor Medical · Cardiovascular
Apr 2023
Decision
310d
Days
Class 2
Risk

About This 510(k) Submission

K221742 is an FDA 510(k) clearance for the CONNEQT PULSE, a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Atcor Medical (Sydney, AU). The FDA issued a Cleared decision on April 21, 2023, 310 days after receiving the submission on June 15, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K221742 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2022
Decision Date April 21, 2023
Days to Decision 310 days
Submission Type Traditional
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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