Cleared Traditional

COSMED K4

K963373 · Cosmed Srl · Anesthesiology
Sep 1997
Decision
379d
Days
Class 2
Risk

About This 510(k) Submission

K963373 is an FDA 510(k) clearance for the COSMED K4, a Calculator, Pulmonary Function Data (Class II — Special Controls, product code BZC), submitted by Cosmed Srl (West Cadwell, US). The FDA issued a Cleared decision on September 10, 1997, 379 days after receiving the submission on August 27, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1880.

Submission Details

510(k) Number K963373 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 1996
Decision Date September 10, 1997
Days to Decision 379 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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