Cleared Traditional

K110429 - PROSIM 4, PROSIM 6, PROSIM 8
(FDA 510(k) Clearance)

K110429 · Fluke Biomedical · Cardiovascular

Sep 2011

Decision

199d

Days

Class 2

Risk

K110429 is an FDA 510(k) clearance for the PROSIM 4, PROSIM 6, PROSIM 8. 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 September 2, 2011, 199 days after receiving the submission on February 15, 2011.

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

Submission Details

510(k) Number	K110429 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 15, 2011
Decision Date	September 02, 2011
Days to Decision	199 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF