Cleared Traditional

COSMED QUARK C12/QUARK T12

K014262 · Cosmed Srl · Cardiovascular
Mar 2002
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K014262 is an FDA 510(k) clearance for the COSMED QUARK C12/QUARK T12, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Cosmed Srl (West Cadwell, US). The FDA issued a Cleared decision on March 26, 2002, 89 days after receiving the submission on December 27, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K014262 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 2001
Decision Date March 26, 2002
Days to Decision 89 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DPS — Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2340