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510(k) K070718

MODIFICATION TO: BODYGUARD INFUSION SYSTEM by Caesarea Medical Electronics , Ltd. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2007
Date Received
March 14, 2007
Clearance Type
Special
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

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  • K060479 — MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM (May 12, 2006)
  • K050800 — NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS (November 23, 2005)
  • 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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