Cleared Abbreviated

K053381 - WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE (FDA 510(k) Clearance)

K053381 · Welch Allyn, Inc. · Anesthesiology device

Jun 2006

Decision

192d

Days

Class 2

Risk

K053381 is an FDA 510(k) clearance for the WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on June 15, 2006, 192 days after receiving the submission on December 5, 2005.

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

Submission Details

510(k) Number	K053381 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 05, 2005
Decision Date	June 15, 2006
Days to Decision	192 days
Submission Type	Abbreviated
Review Panel	Anesthesiology (AN)
Summary	Summary PDF