Cleared Traditional

K223290 - CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) (FDA 510(k) Clearance)

K223290 · Sentiar, Inc. · Cardiovascular device

Jul 2023

Decision

261d

Days

Class 2

Risk

K223290 is an FDA 510(k) clearance for the CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02). This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Sentiar, Inc. (St. Louis, US). The FDA issued a Cleared decision on July 14, 2023, 261 days after receiving the submission on October 26, 2022.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K223290 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 26, 2022
Decision Date	July 14, 2023
Days to Decision	261 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF