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510(k) K772163

DIALYSIS MACHINES DM-346 & 346-1 by Extracorporeal Medical Specialities, Inc. — Product Code FIJ

K772163 is an FDA 510(k) premarket notification submitted by Extracorporeal Medical Specialities, Inc. for the device "DIALYSIS MACHINES DM-346 & 346-1". The FDA issued a decision of Substantially Equivalent on November 28, 1977. The device falls under product code FIJ (System, Dialysate Delivery, Recirculating, 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
November 28, 1977
Date Received
November 16, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Recirculating, 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)

FDA data resources