Cleared Traditional

METAPHOR METABOLIC MONITOR

K093080 · Treymed, Inc. · Anesthesiology
Jan 2010
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K093080 is an FDA 510(k) clearance for the METAPHOR METABOLIC MONITOR, a Computer, Oxygen-uptake (Class II — Special Controls, product code BZL), submitted by Treymed, Inc. (Sussex, US). The FDA issued a Cleared decision on January 22, 2010, 114 days after receiving the submission on September 30, 2009. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1730.

Submission Details

510(k) Number K093080 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2009
Decision Date January 22, 2010
Days to Decision 114 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