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510(k) Clearances
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510(k) K993616
CARDIO-CARD INTERPRETATION SYSTEM I by
Nasiff Assoc., Inc.
— Product Code
LOS
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
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K972795
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— CARDIO-CARD ECG MANAGEMENT SYSTEM (July 9, 1992)
K903722
— MICROMED QRS CARD (December 5, 1990)
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K090895
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— CARDIOVIEW32 REVIEW MODULE (March 10, 2009)
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— 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)