Cleared Traditional

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

K040549 · Cosmed Srl · Anesthesiology

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 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