Cleared Special

K052972 - DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 (FDA 510(k) Clearance)

K052972 · Ge Healthcare · Cardiovascular device

Dec 2005

Decision

66d

Days

Class 2

Risk

K052972 is an FDA 510(k) clearance for the DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3. This device is classified as a System, Network And Communication, Physiological Monitors (Class II - Special Controls, product code MSX).

Submitted by Ge Healthcare (Needham, US). The FDA issued a Cleared decision on December 29, 2005, 66 days after receiving the submission on October 24, 2005.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K052972 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 24, 2005
Decision Date	December 29, 2005
Days to Decision	66 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF