Cleared Traditional

COSMED K5 Wearable Metabolic Technology

K162515 · Cosmed Srl · Anesthesiology
Jun 2017
Decision
285d
Days
Class 2
Risk

About This 510(k) Submission

K162515 is an FDA 510(k) clearance for the COSMED K5 Wearable Metabolic Technology, a Calculator, Pulmonary Function Data (Class II — Special Controls, product code BZC), submitted by Cosmed Srl (Pavona Di Albano Rome, IT). The FDA issued a Cleared decision on June 20, 2017, 285 days after receiving the submission on September 8, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1880.

Submission Details

510(k) Number K162515 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2016
Decision Date June 20, 2017
Days to Decision 285 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZC — Calculator, Pulmonary Function Data
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1880

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