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510(k) K091855

THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000 by Belmont Instrument Corp. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2009
Date Received
June 23, 2009
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

Other clearances by Belmont Instrument Corp.

  • K131519 — BELMONT HYPERTHERMIA PUMP (November 6, 2013)
  • K112639 — THE BELMONT BUDDY LITE FLUID WARMER (November 16, 2011)
  • K090508 — THE BELMONT BUDDY LITE FLUID WARMER (March 26, 2009)
  • K090089 — BELMONT HYPERTHERMIA PUMP (February 12, 2009)
  • K070654 — HYPERTHERMIA PUMP (June 8, 2007)
  • K062774 — BELMONT BUDDY PLUS FLUID WARMER (October 19, 2006)
  • K052547 — BELMONT BUDDY FLUID WARMER (October 13, 2005)
  • K032778 — LARGE VOLUME FLUID RESERVOIR (September 22, 2003)
  • K032674 — BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000 (September 16, 2003)
  • K031478 — MICROHEATER (July 2, 2003)

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