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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K023370
Device Name CHEETAH I.V.D.S., MODEL 2002P
Applicant
Cheetah Medical, Inc.
117 Ahuzah St.
Ra'Ananna 43373,  IL 43373
Applicant Contact ARAVA HACOHEN
Correspondent
Cheetah Medical, Inc.
117 Ahuzah St.
Ra'Ananna 43373,  IL 43373
Correspondent Contact ARAVA HACOHEN
Regulation Number870.1425
Classification Product Code
DQK  
Date Received10/08/2002
Decision Date 12/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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