FDA.reportPublic FDA data

510(k) K241465

Device
Midas Flowmeter; eAVS
Applicant
Parker Hannifin Corporation
510(k) number
K241465
Product code
BZR
Decision
Substantially Equivalent (SESE)
Decision date
2024-09-19
Date received
2024-05-23
Regulation
868.5330
Classification name
Mixer, Breathing Gases, Anesthesia Inhalation
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Deanna Perry
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 BZR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243917F&P Optiflow Air/Oxygen Flow SourceFisher & Paykel Healthcare, Ltd.2025-07-14
K231895Maxtec MaxBlend2+pMaxtec, LLC2023-12-04
K230987FlowStar Analog Mixer FlowmeterBaldus Sedation GmbH & Co. KG2023-09-14
K222794FlowStar Touch Digital Mixer FlowmeterBaldus Sedation GmbH & Co. KG2023-07-28
K221494Quality Mix Blender, OxymixerDehas Medical Systems GmbH2023-01-23
K202480Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50Parker Hannifin2021-04-22
K173205Equinox AdvantageO-Two Medical Technologies, Inc.2018-08-29
K161718MaxBlend 2, MaxBlend LiteMaxtec, LLC2016-10-27
K142291GMX Series Medical Air/Oxygen BlenderGentec (Shanghai) Corporation2015-05-19
K113687EQUINOX RELIEVEO-Two Medical Technologies, Inc.2012-04-30
K113232MAXMIXING BLOCKMaxtec, Inc.2012-03-01
K101286SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04Linde Healthcare AB2011-10-20
K103317RESUSCITATION UNIT 105Atom Medical Corporation2011-04-20
K092484HELIOX LOW FLOW SENTRY BLENDERCardinal Health 207, Inc.2010-04-02
K090781HELIO2 BLENDERPrecision Medical, Inc.2009-08-13