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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name diathermy, shortwave, for use other than applying therapeutic deep heat
510(k) Number K121338
Device Name ZEOBI
Applicant
IVIVI HEALTH SCIENCE, LLC
330 TOWNSEND STREET
SUITE 100
SAN FRANCISCO,  CA  94107
Applicant Contact KATHRYN CLUBB
Correspondent
IVIVI HEALTH SCIENCE, LLC
330 TOWNSEND STREET
SUITE 100
SAN FRANCISCO,  CA  94107
Correspondent Contact KATHRYN CLUBB
Regulation Number890.5290
Classification Product Code
ILX  
Date Received05/03/2012
Decision Date 07/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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