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510(k) K193646

Dynamic Gas Scavenging System 2 (DGSS - 2) by Anesthetic Gas Reclamation, Inc. — Product Code CBN

K193646 is an FDA 510(k) premarket notification submitted by Anesthetic Gas Reclamation, Inc. for the device "Dynamic Gas Scavenging System 2 (DGSS - 2)". The FDA issued a decision of Substantially Equivalent on December 4, 2020. The device falls under product code CBN (Apparatus, Gas-Scavenging), a Class II device regulated under 21 CFR 868.5430. Anesthetic Gas Reclamation, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2020
Date Received
December 30, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Gas-Scavenging
Device Class
Class II
Regulation Number
868.5430
Review Panel
AN
Submission Type

Other clearances by Anesthetic Gas Reclamation, Inc.

  • K063519 — DYNAMIC GAS SCAVENGING SYSTEM (DGSS) (December 1, 2006)

Other clearances for product code CBN

  • K223452 — Nitronox Scavenger Plus (March 5, 2023)
  • K160950 — MINISCAV (May 5, 2017)
  • K142138 — ISO-GARD MASK (October 30, 2014)
  • K132729 — ISO-GARD MASK (January 9, 2014)
  • K123176 — ISO-GARD CLEARAIR MASK (February 14, 2013)
  • K110930 — ACTIVE WASTE GAS SCAVENGER (June 23, 2011)
  • K092031 — VAPOR-CLEAR, MODEL 100 (April 16, 2010)
  • K080039 — PASSIVE WASTE GAS SCAVENGER, MODEL 14600 (April 14, 2008)
  • K072255 — MINRAD INC. NASAL SCAVENGING CIRCUIT (October 18, 2007)
  • K063519 — DYNAMIC GAS SCAVENGING SYSTEM (DGSS) (December 1, 2006)

FDA data resources