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510(k) K993616

CARDIO-CARD INTERPRETATION SYSTEM I by Nasiff Assoc., Inc. — Product Code LOS

K993616 is an FDA 510(k) premarket notification submitted by Nasiff Assoc., Inc. for the device "CARDIO-CARD INTERPRETATION SYSTEM I". The FDA issued a decision of Substantially Equivalent on April 10, 2000. Nasiff Assoc., Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2000
Date Received
October 26, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Nasiff Assoc., Inc.

  • K972795 — CARDIO-CARD MANAGEMENT SYSTEM II (February 20, 1998)
  • 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)

Other clearances for product code LOS

  • K090895 — EKG-PLUS II SOFTWARE (August 26, 2009)
  • K083749 — CARDIOVIEW32 REVIEW MODULE (March 10, 2009)
  • K073376 — PHILIPS ECG ALGORITHM (April 11, 2008)
  • K023034 — CARDIOTOUCH-3000 (November 14, 2002)
  • K011328 — CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH (November 21, 2001)
  • K984465 — OXYCONALPHA WITH OPTION ECG (October 27, 1999)
  • K991014 — CASE 8000 EXERCISE TESTING SYSTEM (October 20, 1999)
  • K991735 — MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 (August 19, 1999)
  • K990031 — NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES (April 16, 1999)
  • K984504 — NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES (April 15, 1999)

FDA data resources