Cleared Traditional

K220362 - LE-12CH (FDA 510(k) Clearance)

K220362 · Caf Medical Solutions, Inc. · Cardiovascular device

Mar 2022

Decision

45d

Days

Class 2

Risk

K220362 is an FDA 510(k) clearance for the LE-12CH. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).

Submitted by Caf Medical Solutions, Inc. (Hockley, US). The FDA issued a Cleared decision on March 25, 2022, 45 days after receiving the submission on February 8, 2022.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number	K220362 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 08, 2022
Decision Date	March 25, 2022
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF