Cleared Traditional

K121722 - ESA620 ELECTRICAL SAFETY ANALYZER
(FDA 510(k) Clearance)

K121722 · Fluke Biomedical · Cardiovascular

Oct 2012

Decision

121d

Days

Class 2

Risk

K121722 is an FDA 510(k) clearance for the ESA620 ELECTRICAL SAFETY ANALYZER. 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 October 11, 2012, 121 days after receiving the submission on June 12, 2012.

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

Submission Details

510(k) Number	K121722 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 12, 2012
Decision Date	October 11, 2012
Days to Decision	121 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF