Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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 St.
Somerville,  MA  02144
Applicant Contact Jon Bloom
Correspondent
Podimetrics,Inc.
231 R Holland St.
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
Predetermined Change
Control Plan Authorized		 No
-
-