Cleared Traditional

K221260 - CSF-3 (FDA 510(k) Clearance)

K221260 · Cardiacsense · Cardiovascular device

Jan 2023

Decision

249d

Days

Class 2

Risk

K221260 is an FDA 510(k) clearance for the CSF-3. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).

Submitted by Cardiacsense (Caesarea, IL). The FDA issued a Cleared decision on January 6, 2023, 249 days after receiving the submission on May 2, 2022.

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

Submission Details

510(k) Number	K221260 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 02, 2022
Decision Date	January 06, 2023
Days to Decision	249 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF