Cleared Traditional

K083448 - CABLE, TRANSDUCER, MODEL 2400GN (FDA 510(k) Clearance)

K083448 · Conmed Corporation · Anesthesiology device

Aug 2009

Decision

272d

Days

Class 2

Risk

K083448 is an FDA 510(k) clearance for the CABLE, TRANSDUCER, MODEL 2400GN. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on August 20, 2009, 272 days after receiving the submission on November 21, 2008.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number	K083448 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 21, 2008
Decision Date	August 20, 2009
Days to Decision	272 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF