Cleared Traditional

NARKOMED 6000

K993826 · Draeger Medical, Inc. · Cardiovascular

Mar 2000

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K993826 is an FDA 510(k) clearance for the NARKOMED 6000, a Monitor, St Segment (Class II — Special Controls, product code MLC), submitted by Draeger Medical, Inc. (Telford, US). The FDA issued a Cleared decision on March 23, 2000, 132 days after receiving the submission on November 12, 1999. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number	K993826 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 12, 1999
Decision Date	March 23, 2000
Days to Decision	132 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF