Cleared Traditional

Savina 300

K180779 · Dragerwerk AG & CO Kgaa · Anesthesiology
Jan 2019
Decision
297d
Days
Class 2
Risk

About This 510(k) Submission

K180779 is an FDA 510(k) clearance for the Savina 300, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Dragerwerk AG & CO Kgaa (L?beck, DE). The FDA issued a Cleared decision on January 17, 2019, 297 days after receiving the submission on March 26, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K180779 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2018
Decision Date January 17, 2019
Days to Decision 297 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBK — Ventilator, Continuous, Facility Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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