Cleared Traditional

BIOMODULE 3-M1

K123658 · Zephyr Technology Corporation · Cardiovascular

Apr 2013

Decision

147d

Days

Class 2

Risk

About This 510(k) Submission

K123658 is an FDA 510(k) clearance for the BIOMODULE 3-M1, a Electrode, Electrocardiograph (Class II — Special Controls, product code DRX), submitted by Zephyr Technology Corporation (Stamford, US). The FDA issued a Cleared decision on April 24, 2013, 147 days after receiving the submission on November 28, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2360.

Submission Details

510(k) Number	K123658 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 28, 2012
Decision Date	April 24, 2013
Days to Decision	147 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF