Cleared Traditional

K102974 - INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00 (FDA 510(k) Clearance)

K102974 · Philips Medical Systems · Cardiovascular device

Jan 2011

Decision

90d

Days

Class 2

Risk

K102974 is an FDA 510(k) clearance for the INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00. This device is classified as a System, Network And Communication, Physiological Monitors (Class II - Special Controls, product code MSX).

Submitted by Philips Medical Systems (Boca Raton, US). The FDA issued a Cleared decision on January 4, 2011, 90 days after receiving the submission on October 6, 2010.

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

Submission Details

510(k) Number	K102974 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 06, 2010
Decision Date	January 04, 2011
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF