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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K984298
Device Name Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI
Applicant
Z-KAT, INC.
11645 BISCAYNE BLVD.
SUITE 304
MIAMI,  FL  33181
Applicant Contact RONY ABOVITZ
Correspondent
Z-KAT, INC.
11645 BISCAYNE BLVD.
SUITE 304
MIAMI,  FL  33181
Correspondent Contact RONY ABOVITZ
Regulation Number882.4560
Classification Product Code
HAW  
Date Received12/02/1998
Decision Date 06/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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