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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 K013349
Device Name ASTRONOMER PLUS SYSTEM
Applicant
EP TECHNOLOGIES, INC.
2710 ORCHARD PKWY.
SAN JOSE,  CA  95134
Applicant Contact ANDREA L RUTH
Correspondent
EP TECHNOLOGIES, INC.
2710 ORCHARD PKWY.
SAN JOSE,  CA  95134
Correspondent Contact ANDREA L RUTH
Regulation Number870.1425
Classification Product Code
DQK  
Date Received10/09/2001
Decision Date 04/09/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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