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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Impedance
510(k) Number K070985
Device Name AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC
Applicant
Osypka Medical, Inc.
7855 Ivanhoe Ave., Suite 226
La Jolla,  CA  92037
Applicant Contact MARKUS OSYPKA
Correspondent
Osypka Medical, Inc.
7855 Ivanhoe Ave., Suite 226
La Jolla,  CA  92037
Correspondent Contact MARKUS OSYPKA
Regulation Number870.2770
Classification Product Code
DSB  
Date Received04/06/2007
Decision Date 02/01/2008
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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