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 Number | 890.5050
|
Classification Product Code |
|
Date Received | 03/04/2015 |
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
|
|
|