Cleared Special

Dynamic Gas Scavenging System 2 (DGSS - 2)

K193646 · Anesthetic Gas Reclamation, Inc. · Anesthesiology

Dec 2020

Decision

340d

Days

Class 2

Risk

About This 510(k) Submission

K193646 is an FDA 510(k) clearance for the Dynamic Gas Scavenging System 2 (DGSS - 2), a Apparatus, Gas-scavenging (Class II — Special Controls, product code CBN), submitted by Anesthetic Gas Reclamation, Inc. (Dallas, US). The FDA issued a Cleared decision on December 4, 2020, 340 days after receiving the submission on December 30, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5430.

Submission Details

510(k) Number	K193646 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 30, 2019
Decision Date	December 04, 2020
Days to Decision	340 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF