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510(k) K855001

FRESENIUS HEMODIALYSIS MACHINE A1008 BSM by Seratronics, Inc. — Product Code FLC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1986
Date Received
December 13, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Station, Dialysis Control, Negative Pressure Type
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 FLC

  • K910656 — WILSON-COOK DISPOSABLE BIOPSY FORCEPS (April 25, 1991)
  • K791164 — NEGATOVE PRESSURE CONVERTOR (October 4, 1979)
  • K760725 — COIL MACHINE ADAPTER (October 27, 1976)