Cleared Traditional

PRIMUS US

K042607 · Draeger Medical, Inc. · Anesthesiology
Nov 2004
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K042607 is an FDA 510(k) clearance for the PRIMUS US, a Gas-machine, Anesthesia (Class II — Special Controls, product code BSZ), submitted by Draeger Medical, Inc. (Telford, US). The FDA issued a Cleared decision on November 26, 2004, 63 days after receiving the submission on September 24, 2004. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K042607 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2004
Decision Date November 26, 2004
Days to Decision 63 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSZ — Gas-machine, Anesthesia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5160

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