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510(k) K990031

NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES by Nihon Kohden America, Inc. — Product Code LOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1999
Date Received
January 5, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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  • K991735 — MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 (August 19, 1999)
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