Cleared Special

K053027 - VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300) (FDA 510(k) Clearance)

K053027 · Welch Allyn, Inc. · Cardiovascular device

Nov 2005

Decision

26d

Days

Class 2

Risk

K053027 is an FDA 510(k) clearance for the VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300). 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 November 22, 2005, 26 days after receiving the submission on October 27, 2005.

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

Submission Details

510(k) Number	K053027 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 27, 2005
Decision Date	November 22, 2005
Days to Decision	26 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