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510(k) K082758

PRISMAFLO II by Stihler Electronic GmbH — Product Code KOC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2008
Date Received
September 19, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Blood Circuit, Hemodialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Stihler Electronic GmbH

  • K202197 — Astopad Patient Warming System (September 4, 2020)
  • K082765 — ASTOFLO PLUS (December 18, 2008)
  • K020103 — PRISMAFLO (July 24, 2002)
  • K991159 — PRISMATHERM II, ASTOLINE (September 3, 1999)
  • K991160 — ASTOTHERM PLUS, ASTOTUBES, ASTOLINE (September 2, 1999)

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