Cleared Special

K110516 - CONNEX VITAL SIGNS MONITOR 6000 SERIES (FDA 510(k) Clearance)

K110516 · Welch Allyn, Inc. · Cardiovascular device

Jun 2011

Decision

98d

Days

Class 2

Risk

K110516 is an FDA 510(k) clearance for the CONNEX VITAL SIGNS MONITOR 6000 SERIES. This device is classified as a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MWI).

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on June 1, 2011, 98 days after receiving the submission on February 23, 2011.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K110516 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 23, 2011
Decision Date	June 01, 2011
Days to Decision	98 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class	Class II - Special Controls
CFR Regulation	21 CFR 870.2300