Cleared Traditional

K121860 - ESA615
(FDA 510(k) Clearance)

K121860 · Fluke Biomedical · Cardiovascular

Jan 2013

Decision

213d

Days

Class 2

Risk

K121860 is an FDA 510(k) clearance for the ESA615. This device is classified as a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II — Special Controls, product code DRT).

Submitted by Fluke Biomedical (Cleveland, US). The FDA issued a Cleared decision on January 25, 2013, 213 days after receiving the submission on June 26, 2012.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K121860 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 26, 2012
Decision Date	January 25, 2013
Days to Decision	213 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF