Cleared Traditional

EndoPATx

K211557 · Itamar Medical , Ltd. · Cardiovascular
Dec 2022
Decision
589d
Days
Class 2
Risk

About This 510(k) Submission

K211557 is an FDA 510(k) clearance for the EndoPATx, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Itamar Medical , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on December 29, 2022, 589 days after receiving the submission on May 19, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K211557 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 2021
Decision Date December 29, 2022
Days to Decision 589 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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