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510(k) K897074

MODEL 215M PATIENT SIMULATOR by Dynatech/Nevada, Inc. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1990
Date Received
December 22, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
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)
  • K897029 — MODEL ECG100 SIMULATOR (April 26, 1990)
  • K897096 — MODEL 404A I.V. INFUSION PUMP ANALYZER (March 15, 1990)

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