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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Image Processing, Radiological
510(k) Number K960946
Device Name ECHONET
Applicant
Lockheed Martin Communications Systems
1 Federal St.
Camden,  NJ  08103
Applicant Contact VINCENT J NAPOLEON
Correspondent
Lockheed Martin Communications Systems
1 Federal St.
Camden,  NJ  08103
Correspondent Contact VINCENT J NAPOLEON
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/08/1996
Decision Date 05/07/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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