Device Classification Name |
infrared hematoma detector
|
510(k) Number |
K211617 |
Device Name |
Infrascanner |
Applicant |
Infrascan, Inc. |
3508 Market Street |
Philadelphia,
PA
19104
|
|
Applicant Contact |
Baruch Ben Dor |
Correspondent |
NAMSA |
400 US-169 |
Minneapolis,
MN
55441
|
|
Correspondent Contact |
Angela Mallery |
Regulation Number | 882.1935
|
Classification Product Code |
|
Date Received | 05/26/2021 |
Decision Date | 02/09/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|