Cleared Traditional

SPIROPALM

K093174 · Cosmed Srl · Anesthesiology
Feb 2010
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K093174 is an FDA 510(k) clearance for the SPIROPALM, a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Cosmed Srl (West Caldwell, US). The FDA issued a Cleared decision on February 26, 2010, 141 days after receiving the submission on October 8, 2009. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K093174 FDA.gov
FDA Decision Cleared SESE
Date Received October 08, 2009
Decision Date February 26, 2010
Days to Decision 141 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BZG — Spirometer, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1840