Cleared Traditional

K032831 - PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200 (FDA 510(k) Clearance)

K032831 · Conmed Corporation · Anesthesiology device

Aug 2004

Decision

355d

Days

Class 2

Risk

K032831 is an FDA 510(k) clearance for the PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200. 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 31, 2004, 355 days after receiving the submission on September 11, 2003.

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

Submission Details

510(k) Number	K032831 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 11, 2003
Decision Date	August 31, 2004
Days to Decision	355 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF