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510(k) K060296

NXSTAGE DIALYSATE PREPARATION MODULE by Nxstage Medical, Inc. — Product Code FKR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2006
Date Received
February 6, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Subsystem, Proportioning
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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Other clearances for product code FKR

  • K140571 — NXSTAGE PUREFLOW SL (May 15, 2014)
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  • K043436 — NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 (March 17, 2005)
  • K850435 — SARTORIUS AQUASART SM 40035 - DIALYSATE SYS (June 4, 1985)
  • K850756 — AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS (March 20, 1985)
  • K810605 — CHEMATIC BICARBONATE DIALYSATE SYSTEM (June 16, 1981)
  • K810127 — GAMBRO BICARBONATE MODULE, BCM-10 (February 25, 1981)
  • K802465 — BICARB-O-MATE HEMODIALYSIS SOD. BICARB. (November 12, 1980)
  • K800772 — MOD. DM-357 BICARBONATE RETROFIT KIT (May 14, 1980)