Cleared Traditional

FITMATE SERIES

K071533 · Cosmed Srl · Anesthesiology
Sep 2007
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K071533 is an FDA 510(k) clearance for the FITMATE SERIES, a Computer, Oxygen-uptake (Class II — Special Controls, product code BZL), submitted by Cosmed Srl (West Caldwell, US). The FDA issued a Cleared decision on September 28, 2007, 115 days after receiving the submission on June 5, 2007. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1730.

Submission Details

510(k) Number K071533 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 2007
Decision Date September 28, 2007
Days to Decision 115 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZL — Computer, Oxygen-uptake
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1730