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510(k) K000702

BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR by Fresenius Medical Care North America — Product Code FIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2000
Date Received
March 1, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protector, Transducer, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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  • K131611 — FRESENIUS DRY ACID DISSOLUTION UNITS (August 29, 2013)
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  • K121341 — FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM (December 6, 2012)
  • K120017 — FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM (February 2, 2012)
  • K113427 — FRESENIUS 2008T HEMODIALYSIS MACHINE (December 21, 2011)

Other clearances for product code FIB

  • K240164 — NovaLine SP-C35 Transducer Protector (956007) (June 28, 2024)
  • K072988 — NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 (February 21, 2008)
  • K001971 — HEMODIALYSIS TUBING SETS (May 24, 2001)
  • K010264 — NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING S (April 27, 2001)
  • K001465 — NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING S (December 5, 2000)
  • K003445 — FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2 (December 1, 2000)
  • K983076 — MEDISYSTEMS TRANSDUCER PROTECTOR (November 25, 1998)
  • K964337 — BETTER-BLADDER (BB) (May 23, 1997)
  • K970536 — MEDISYSTEMS TRANDUCER PROTECTOR (May 12, 1997)
  • K934069 — MILLEX, DUALEX (PLUS, ULTRA) (April 21, 1994)