Cleared Traditional

K172221 - VTRUST Vital Signs Monitor, Model: TD-2300 (FDA 510(k) Clearance)

Also includes:

FORA Vital Signs Monitor, Model: VSM100

K172221 · Taidoc Technology Corporation · Cardiovascular device

Jun 2018

Decision

317d

Days

Class 2

Risk

K172221 is an FDA 510(k) clearance for the VTRUST Vital Signs Monitor, Model: TD-2300. This device is classified as a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MWI).

Submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on June 6, 2018, 317 days after receiving the submission on July 24, 2017.

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

Submission Details

510(k) Number	K172221 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 24, 2017
Decision Date	June 06, 2018
Days to Decision	317 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