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510(k) K905498

STAT 2 IV PUMPETTE by The Master Medical Corp. — Product Code LDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1991
Date Received
December 7, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Infusion, Intravascular, Electronic
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by The Master Medical Corp.

  • K913076 — I.V. INSTANT TIMER (October 17, 1991)
  • K905497 — MASTER FLOW I.V. PUMPETTE (April 16, 1991)
  • K871753 — MASTER MEDICAL DEVICE IS I.V. STAT 2 (June 5, 1987)
  • K852254 — I.V. STAT MASTER (November 18, 1985)
  • K792560 — MASTER I.V. DIAL LOCK (December 20, 1979)

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  • K971865 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P (July 3, 1997)
  • K934543 — UNIVERSAL CONTROLLER, MODEL 100 (March 29, 1994)
  • K935236 — FLOW CONTROLLING EXTENSION SET (February 24, 1994)
  • K905497 — MASTER FLOW I.V. PUMPETTE (April 16, 1991)
  • K896907 — 3M IV FLOW REGULATOR (February 26, 1990)