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510(k) K897096

MODEL 404A I.V. INFUSION PUMP ANALYZER by Dynatech/Nevada, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1990
Date Received
December 21, 1989
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 Dynatech/Nevada, Inc.

  • K942546 — CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER (January 27, 1995)
  • K935817 — MEDSIM 300 PATIENT SIMULATOR (January 18, 1994)
  • K934254 — IMPULSE 3000 DEFIBRILLATOR ANALYZER (November 23, 1993)
  • K897074 — MODEL 215M PATIENT SIMULATOR (May 17, 1990)
  • K897029 — MODEL ECG100 SIMULATOR (April 26, 1990)

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