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510(k) K781633

ULTRAFILTRATION SCALE by Extracorporeal Medical Specialities, Inc. — Product Code FIL

K781633 is an FDA 510(k) premarket notification submitted by Extracorporeal Medical Specialities, Inc. for the device "ULTRAFILTRATION SCALE". The FDA issued a decision of Substantially Equivalent on December 7, 1978. The device falls under product code FIL (System, Dialysate Delivery, Single Pass), a Class II device regulated under 21 CFR 876.5820. Extracorporeal Medical Specialities, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1978
Date Received
September 21, 1978
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 by Extracorporeal Medical Specialities, Inc.

  • K843955 — EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR (November 29, 1984)
  • K840532 — HEMOPERFUSION SYSTEM TP-400 (May 30, 1984)
  • K840262 — HANCOCK PERICARDIAL PATCH (May 30, 1984)
  • K840146 — EXP* 700 PARALLEL PLATE DIALYZER (February 4, 1984)
  • K840057 — EXP* 500 PARALLEL PLATE DIALYZER (February 4, 1984)
  • K832547 — ULTRAFILTRATION CONTROLLER (January 3, 1984)
  • K831423 — THERAPEUTIC EXCHANGE SYSTEM (January 3, 1984)
  • K833477 — INTERSEPT 40 MICRON FILTER (December 27, 1983)
  • K833476 — INTERSEPT 40 MICRON FILTER W/TUBING (December 27, 1983)
  • K831424 — THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 (October 14, 1983)

Other clearances for product code FIL

  • K011741 — CRIT-LINE MONITOR III TQA (CLM TQA) (July 23, 2002)
  • 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)
  • K771875 — ULTRAFILTRATION MONITOR 5M9034 (November 30, 1977)
  • K771227 — AK-10 (August 2, 1977)
  • K770137 — NEGATIVE PRESSURE ADAPTER 5M1350 (February 1, 1977)

FDA data resources