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510(k) K011741

CRIT-LINE MONITOR III TQA (CLM TQA) by Hemametrics — Product Code FIL

K011741 is an FDA 510(k) premarket notification submitted by Hemametrics for the device "CRIT-LINE MONITOR III TQA (CLM TQA)". The FDA issued a decision of Substantially Equivalent on July 23, 2002. The device falls under product code FIL (System, Dialysate Delivery, Single Pass), a Class II device regulated under 21 CFR 876.5820.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2002
Date Received
June 5, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Single Pass
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances for product code FIL

  • K901038 — SPS 550-IPS (INTEGRATED PATIENT STATION) (April 19, 1990)
  • K890329 — FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM (May 11, 1989)
  • K790824 — REPGREEN ULTRAFILTRATION MONITOR (June 27, 1979)
  • K781633 — ULTRAFILTRATION SCALE (December 7, 1978)
  • K771875 — ULTRAFILTRATION MONITOR 5M9034 (November 30, 1977)
  • K771227 — AK-10 (August 2, 1977)
  • K770137 — NEGATIVE PRESSURE ADAPTER 5M1350 (February 1, 1977)

FDA data resources