Cleared Traditional

K040549 - COSMED PONY FX (FDA 510(k) Clearance)

K040549 · Cosmed Srl · Anesthesiology device
Sep 2004
Decision
210d
Days
Class 2
Risk

K040549 is an FDA 510(k) clearance for the COSMED PONY FX. This device is classified as a Calculator, Predicted Values, Pulmonary Function (Class II - Special Controls, product code BTY).

Submitted by Cosmed Srl (West Cadwell, US). The FDA issued a Cleared decision on September 28, 2004, 210 days after receiving the submission on March 2, 2004.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number K040549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2004
Decision Date September 28, 2004
Days to Decision 210 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BTY - Calculator, Predicted Values, Pulmonary Function
Device Class Class II - Special Controls
CFR Regulation 21 CFR 868.1890