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510(k) K213564

Device
BiWaze Clear System
Applicant
Abmrc, LLC
510(k) number
K213564
Product code
NHJ
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-21
Date received
2021-11-09
Regulation
868.5905
Classification name
Device, Positive Pressure Breathing, Intermittent
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Leah Noaeill
Address
860 Blue Gentian Rd., Suite 200 Eagan MN US 55121 55121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NHJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242438ClearoBreas Medical AB2025-05-16
K231728BiWaze Clear SystemAbmrc, LLC2024-04-08
K200988Maximus SystemHill-Rom Services Pte, Ltd.2020-05-26
K191912BiWaze CoughAbmrc, LLC2020-03-27
K192143Maximus SystemHill-Rom Services Pte, Ltd.2020-02-14
K151689MetaNeb 4 SystemHill-Rom Services Pte, Ltd.2016-03-17
K140598PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERCDima Italia Srl2014-10-16
K140605MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERCDima Italia Srl2014-10-03
K132988VITAL COUGHLung Assist, Inc.2014-03-28
K124032METANEBHill-Rom Services Pte, Ltd.2013-04-25
K113549COMFORT COUGHSeoil Pacific Corp.2013-02-21
K121955COUGHASSIST T70 DEVICERespironics, Inc.2012-12-14
K120277VITAL COUGHLung Assist, Inc.2012-09-12
K072292NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUSDima Italia Srl2008-01-07
K051964POWERNEBComedica , Inc.2005-12-01