Cleared Special

K093881 - TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR
(FDA 510(k) Clearance)

K093881 · GE Healthcare Finland Oy · Anesthesiology

Mar 2010

Decision

84d

Days

Class 2

Risk

K093881 is an FDA 510(k) clearance for the TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR. This device is classified as a Oximeter (Class II — Special Controls, product code DQA).

Submitted by GE Healthcare Finland Oy (Helsinki, FI). The FDA issued a Cleared decision on March 12, 2010, 84 days after receiving the submission on December 18, 2009.

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

Submission Details

510(k) Number	K093881 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 18, 2009
Decision Date	March 12, 2010
Days to Decision	84 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF