Home / 510(k) Clearances / K982412

510(k) K982412

MODIFICATION OF CRIT-LINE MONITOR III (CLM III) by In-Line Diagnostics Corp. — Product Code MQS

K982412 is an FDA 510(k) premarket notification submitted by In-Line Diagnostics Corp. for the device "MODIFICATION OF CRIT-LINE MONITOR III (CLM III)". The FDA issued a decision of Substantially Equivalent on October 9, 1998. The device falls under product code MQS (System, Hemodialysis, Access Recirculation Monitoring), a Class II device regulated under 21 CFR 876.5820. In-Line Diagnostics Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1998
Date Received
July 13, 1998
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)
  • K972470 — CRIT-LINE MONITOR (CLMIII) (December 11, 1997)
  • K953875 — CRIT-LINE HEMATOCRIT ALERT (MODIFICATION) (July 23, 1996)
  • 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)

FDA data resources