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510(k) K232283

PhySoftAMS® by Physician Software Systems, LLC — Product Code MQS

K232283 is an FDA 510(k) premarket notification submitted by Physician Software Systems, LLC for the device "PhySoftAMS®". The FDA issued a decision of Substantially Equivalent on December 14, 2023. The device falls under product code MQS (System, Hemodialysis, Access Recirculation Monitoring), a Class II device regulated under 21 CFR 876.5820.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2023
Date Received
July 31, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Hemodialysis, Access Recirculation Monitoring
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances for product code MQS

  • K180410 — Dosis SAM (January 16, 2019)
  • K130579 — PHYSOFT AMS (December 19, 2013)
  • K042566 — VASC-ALERT (November 8, 2004)
  • K022963 — TRANSONIC SYRINGE WARMER, MODEL SYR-1000 (December 4, 2002)
  • K021571 — TRANSONIC FLOW-QC SET MODEL ADT1010 (August 12, 2002)
  • K001763 — CRIT-LINE MONITOR III (CLM III) (December 20, 2000)
  • K993587 — HP M2376A DEVICE LINK SYSTEM (January 20, 2000)
  • K992227 — CRIT-LINE MONITOR III (CLM III) (July 30, 1999)
  • K984194 — HP M2376A DEVICE LINK SYSTEM (April 30, 1999)
  • K982412 — MODIFICATION OF CRIT-LINE MONITOR III (CLM III) (October 9, 1998)

FDA data resources