FDA.reportPublic FDA data

510(k) K232283

Device
PhySoftAMS®
Applicant
Physician Software Systems, LLC
510(k) number
K232283
Product code
MQS
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-14
Date received
2023-07-31
Regulation
876.5820
Classification name
System, Hemodialysis, Access Recirculation Monitoring
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Lewis Mitchell
Address
3333 Warrenville Rd., Suite 200 Lisle IL US 60532 60532

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MQS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K180410Dosis SAMDosis, Inc.2019-01-16
K130579PHYSOFT AMSPhysicians Software Systems, LLC2013-12-19
K042566VASC-ALERTVasc-Alert, Inc.2004-11-08
K022963TRANSONIC SYRINGE WARMER, MODEL SYR-1000Transonic Systems, Inc.2002-12-04
K021571TRANSONIC FLOW-QC SET MODEL ADT1010Transonic Systems, Inc.2002-08-12
K001763CRIT-LINE MONITOR III (CLM III)In-Line Diagnostics Corp.2000-12-20
K993587HP M2376A DEVICE LINK SYSTEMHewlett-Packard Co.2000-01-20
K992227CRIT-LINE MONITOR III (CLM III)In-Line Diagnostics Corp.1999-07-30
K984194HP M2376A DEVICE LINK SYSTEMHewlett-Packard Co.1999-04-30
K982412MODIFICATION OF CRIT-LINE MONITOR III (CLM III)In-Line Diagnostics Corp.1998-10-09
K980906TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-COTransonic Systems, Inc.1998-10-06
K972470CRIT-LINE MONITOR (CLMIII)In-Line Diagnostics Corp.1997-12-11
K960817HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)Transonic Systems, Inc.1997-02-11
K954003COBE HEMODYNAMIC RECIRCULATION MONITORCobe Renal Care, Inc.1997-02-06
K953875CRIT-LINE HEMATOCRIT ALERT (MODIFICATION)In-Line Diagnostics Corp.1996-07-23