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510(k) K781232

Device
IPPB ASSEMBLY W/NEBULIZER
Applicant
RTEC
510(k) number
K781232
Product code
NHJ  
Decision
Substantially Equivalent (SESE)
Decision date
1978-09-27
Date received
1978-07-21
Regulation
868.5905
Classification name
Device, Positive Pressure Breathing, Intermittent
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K213564BiWaze Clear SystemAbmrc, LLC2022-12-21
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

Legacy Summary#

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FDA Review#

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