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510(k) K050800

NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS by Caesarea Medical Electronics , Ltd. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2005
Date Received
March 30, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Caesarea Medical Electronics , Ltd.

  • K080954 — T34L SYRINGE DRIVER (May 16, 2008)
  • K070235 — BODYGUARD PAIN MANAGER INFUSION SYSTEM (May 18, 2007)
  • K070718 — MODIFICATION TO: BODYGUARD INFUSION SYSTEM (April 13, 2007)
  • K061325 — BODYGAURD PAIN MANAGER INFUSION SYSTEM (August 24, 2006)
  • K060479 — MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM (May 12, 2006)
  • K042696 — BODYGUARD INFUSION PUMP SYSTEM (March 11, 2005)
  • K040957 — NOA III ENTERAL NUTRITION PUMP (May 21, 2004)
  • K031749 — BODYGUARD INFUSION SYSTEM (August 21, 2003)

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