Cleared Special

K060254 - MODIFICATION TO INFINITY EXPLORER (FDA 510(k) Clearance)

K060254 · Draeger Medical Systems, Inc. · Cardiovascular device

Apr 2006

Decision

62d

Days

Class 2

Risk

K060254 is an FDA 510(k) clearance for the MODIFICATION TO INFINITY EXPLORER. This device is classified as a System, Network And Communication, Physiological Monitors (Class II - Special Controls, product code MSX).

Submitted by Draeger Medical Systems, Inc. (Danvers, US). The FDA issued a Cleared decision on April 4, 2006, 62 days after receiving the submission on February 1, 2006.

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

Submission Details

510(k) Number	K060254 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 01, 2006
Decision Date	April 04, 2006
Days to Decision	62 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF