Cleared Special

K102389 - NAVIGATOR APPLICATIONS SUITE
(FDA 510(k) Clearance)

K102389 · GE Healthcare Finland Oy · Anesthesiology

Jun 2011

Decision

291d

Days

Class 2

Risk

K102389 is an FDA 510(k) clearance for the NAVIGATOR APPLICATIONS SUITE. This device is classified as a Gas-machine, Anesthesia (Class II — Special Controls, product code BSZ).

Submitted by GE Healthcare Finland Oy (Madison, US). The FDA issued a Cleared decision on June 10, 2011, 291 days after receiving the submission on August 23, 2010.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number	K102389 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 23, 2010
Decision Date	June 10, 2011
Days to Decision	291 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF