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510(k) K043436

NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 by Nxstage Medical, Inc. — Product Code FKR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2005
Date Received
December 13, 2004
Clearance Type
Traditional
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

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  • 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)