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510(k) K844641

FRESENIUS HAEMODIALYSIS ;MACHINE A1008 by Seratronics, Inc. — Product Code FKQ

K844641 is an FDA 510(k) premarket notification submitted by Seratronics, Inc. for the device "FRESENIUS HAEMODIALYSIS ;MACHINE A1008". The FDA issued a decision of Substantially Equivalent on February 14, 1985. The device falls under product code FKQ (System, Dialysate Delivery, Central Multiple Patient), a Class II device regulated under 21 CFR 876.5820. Seratronics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1985
Date Received
November 28, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Central Multiple Patient
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Seratronics, Inc.

  • K955299 — DPS 4 DIALYZER PREPARATION SYSTEM (October 21, 1996)
  • K931336 — DRS 4 DIALYZER REPROCESSING SYSTEM (April 18, 1996)
  • K944539 — DRS 4 ND DIALYZER REPROCESSING SYSTEM (November 29, 1995)
  • K923529 — DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES (August 29, 1994)
  • K914580 — DRS-4 DIALYZER REPROCESSING SYSTEM (February 24, 1992)
  • K874573 — FRESENIUS PURISTERIL 340 (TM) (April 25, 1988)
  • K874872 — FRESENIUS HEMOFLOW F3, F4, F5, F7 (February 19, 1988)
  • K870725 — FRESENIUS HEMOFLOW F6 AND F8 (May 1, 1987)
  • K870724 — FRESENIUS HEMOFLOW F60 AND F80 (April 1, 1987)
  • K864587 — FRESENIUS ULTRAFLUX AV400, AV600 (March 3, 1987)

Other clearances for product code FKQ

  • K052764 — DIACAP ULTRA DIALYSIS FLUID FILTER (June 9, 2006)
  • K893612 — TWO TANK DISSOLUTION MODULE (July 24, 1989)
  • K874084 — MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM (April 27, 1988)
  • K873421 — KAWASUMI A.V. FISTULA SET (October 9, 1987)
  • K870889 — ACID FUCHSIN SOLUTIONS (July 8, 1987)
  • K861730 — ACTRIL FOR KIDNEY MACHINE DISINFECTANT (June 9, 1987)
  • K864635 — FOUR TANK DISSOLUTION MODULE (January 13, 1987)
  • K862304 — DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM (September 9, 1986)
  • K861472 — MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445 (July 10, 1986)
  • K852359 — AMUCHINA/DIALYZER DISINFECTANT (May 13, 1986)

FDA data resources