Device Classification Name |
Cranial Measurement Software
|
510(k) Number |
K212045 |
Device Name |
SoftSpot |
Applicant |
PediaMetrix, Inc. |
155 Gibbs Street, Suite 537 |
Rockville,
MD
20850
|
|
Applicant Contact |
Joshua D Levin |
Correspondent |
PediaMetrix, Inc. |
155 Gibbs Street, Suite 537 |
Rockville,
MD
20850
|
|
Correspondent Contact |
Joshua D Levin |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 06/30/2021 |
Decision Date | 09/28/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|