Cleared Special

TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR

K132696 · GE Healthcare Finland Oy · Anesthesiology
Sep 2013
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K132696 is an FDA 510(k) clearance for the TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR, a Oximeter (Class II — Special Controls, product code DQA), submitted by GE Healthcare Finland Oy (Needham, US). The FDA issued a Cleared decision on September 27, 2013, 29 days after receiving the submission on August 29, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K132696 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2013
Decision Date September 27, 2013
Days to Decision 29 days
Submission Type Special
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

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