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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name foot examination tool for inflammatory changes
510(k) Number K150557
Device Name Podimetrics Remote Temperature Monitoring System
Applicant
Podimetrics, Inc.
231 R Holland Street
Somerville,  MA  02144
Applicant Contact Jon Bloom
Correspondent
Podimetrics, Inc.
231 R Holland Street
Somerville,  MA  02144
Correspondent Contact Jon Bloom
Regulation Number890.5050
Classification Product Code
OIZ  
Date Received03/04/2015
Decision Date 10/08/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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