Cleared Traditional

K110893 - VTRUST FINGER TYPE PULSE OXIMETER (FDA 510(k) Clearance)

Nov 2011
Decision
237d
Days
Class 2
Risk

K110893 is an FDA 510(k) clearance for the VTRUST FINGER TYPE PULSE OXIMETER. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Taidoc Technology Corporation (Taipei County, TW). The FDA issued a Cleared decision on November 22, 2011, 237 days after receiving the submission on March 30, 2011.

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

Submission Details

510(k) Number K110893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2011
Decision Date November 22, 2011
Days to Decision 237 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DQA — Oximeter
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.2700