Cleared Traditional

MODEL 621/624 BIOMAGNETOMETER

K151135 · Tristan Technologies, Inc. · Cardiovascular

Mar 2016

Decision

321d

Days

Class 2

Risk

About This 510(k) Submission

K151135 is an FDA 510(k) clearance for the MODEL 621/624 BIOMAGNETOMETER, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Tristan Technologies, Inc. (San Diego, US). The FDA issued a Cleared decision on March 15, 2016, 321 days after receiving the submission on April 29, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number	K151135 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 29, 2015
Decision Date	March 15, 2016
Days to Decision	321 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF