FDA.reportPublic FDA data

510(k) K223452

Device
Nitronox Scavenger Plus
Applicant
Parker Hannifin Corporation
510(k) number
K223452
Product code
CBN
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-05
Date received
2022-11-15
Regulation
868.5430
Classification name
Apparatus, Gas-Scavenging
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Dylan Alu
Address
245 Township Line Rd. Hatfield PA US 19440 19440

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CBN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K193646Dynamic Gas Scavenging System 2 (DGSS - 2)Anesthetic Gas Reclamation, Inc.2020-12-04
K160950MINISCAVSedation Systems, LLC2017-05-05
K142138ISO-GARD MASKTeleflexmedical, Inc.2014-10-30
K132729ISO-GARD MASKTeleflexmedical, Inc.2014-01-09
K123176ISO-GARD CLEARAIR MASKTeleflexmedical, Inc.2013-02-14
K110930ACTIVE WASTE GAS SCAVENGERG. Dundas Co.,Inc.2011-06-23
K092031VAPOR-CLEAR, MODEL 100Axon Medical, Inc.2010-04-16
K080039PASSIVE WASTE GAS SCAVENGER, MODEL 14600G. Dundas Co.,Inc.2008-04-14
K072255MINRAD INC. NASAL SCAVENGING CIRCUITMinrad, Inc.2007-10-18
K063519DYNAMIC GAS SCAVENGING SYSTEM (DGSS)Anesthetic Gas Reclamation, LLC2006-12-01
K033028ANEFIN, MODEL 100Axon Medical2005-07-22
K033503RFS VACUUM GAUGE SCAVENGING CIRCUITAccutron, Inc.2004-03-12
K981754AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000Porter Instrument Co., Inc.1998-06-16
K963601MODEL 1920 WASTE GAS SCAVENGERG. Dundas Co.1997-04-28
K965239PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U)Accutron, Inc.1997-03-28