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510(k) K953875

CRIT-LINE HEMATOCRIT ALERT (MODIFICATION) by In-Line Diagnostics Corp. — Product Code MQS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1996
Date Received
June 28, 1995
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 by In-Line Diagnostics Corp.

  • K001763 — CRIT-LINE MONITOR III (CLM III) (December 20, 2000)
  • K992227 — CRIT-LINE MONITOR III (CLM III) (July 30, 1999)
  • K983551 — CRIT-SCAN II MONITOR (May 27, 1999)
  • K982412 — MODIFICATION OF CRIT-LINE MONITOR III (CLM III) (October 9, 1998)
  • K972470 — CRIT-LINE MONITOR (CLMIII) (December 11, 1997)
  • K950942 — CRIT-LINE HEMATOCRIT ALERT (March 14, 1995)
  • K935958 — CRIT-LINE BLOOD CHAMBER WITH E-BEAM (January 19, 1995)

Other clearances for product code MQS

  • K232283 — PhySoftAMS® (December 14, 2023)
  • 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)