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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
Predetermined Change
Control Plan Authorized		 No
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