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510(k) K972795

CARDIO-CARD MANAGEMENT SYSTEM II by Nasiff Assoc., Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1998
Date Received
July 28, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

Other clearances by Nasiff Assoc., Inc.

  • K993616 — CARDIO-CARD INTERPRETATION SYSTEM I (April 10, 2000)
  • K960544 — CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM (August 7, 1996)
  • K920020 — CARDIO-CARD ECG MANAGEMENT SYSTEM (July 9, 1992)
  • K903722 — MICROMED QRS CARD (December 5, 1990)

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