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510(k) K992044

INFUSION DYNAMICS POWER INFUSER MODEL M100B by Infusion Dynamics, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1999
Date Received
June 17, 1999
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 Infusion Dynamics, Inc.

  • K030739 — INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE (January 14, 2004)
  • K974074 — INFUSION DYNAMICS POWER INFUSER (February 17, 1998)

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