Cleared Traditional

K200856 - SmartLinx Vitals Plus Patient Monitoring System (FDA 510(k) Clearance)

K200856 · Capsule Technologie Sas · Cardiovascular device

Jul 2020

Decision

100d

Days

Class 2

Risk

K200856 is an FDA 510(k) clearance for the SmartLinx Vitals Plus Patient Monitoring System. This device is classified as a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MWI).

Submitted by Capsule Technologie Sas (Andover, US). The FDA issued a Cleared decision on July 10, 2020, 100 days after receiving the submission on April 1, 2020.

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

Submission Details

510(k) Number	K200856 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 01, 2020
Decision Date	July 10, 2020
Days to Decision	100 days
Submission Type	Traditional
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