Cleared Traditional

K103802 - TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR
(FDA 510(k) Clearance)

K103802 · GE Healthcare Finland Oy · Anesthesiology

Aug 2011

Decision

217d

Days

Class 2

Risk

K103802 is an FDA 510(k) clearance for the TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR, a Oximeter (Class II — Special Controls, product code DQA), submitted by GE Healthcare Finland Oy (Helsinki, FI). The FDA issued a Cleared decision on August 2, 2011, 217 days after receiving the submission on December 28, 2010. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number	K103802 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 28, 2010
Decision Date	August 02, 2011
Days to Decision	217 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF