Device Classification Name |
Infrared Hematoma Detector
|
510(k) Number |
K120949 |
Device Name |
INFRASCANNER |
Applicant |
INFRASCAN, INC. |
1835 MARKET ST., 29TH FLOOR |
PHILADELPHIA,
PA
19103
|
|
Applicant Contact |
STEVEN B DATLOF, M.D., J.D. |
Correspondent |
INFRASCAN, INC. |
1835 MARKET ST., 29TH FLOOR |
PHILADELPHIA,
PA
19103
|
|
Correspondent Contact |
STEVEN B DATLOF, M.D., J.D. |
Regulation Number | 882.1935
|
Classification Product Code |
|
Date Received | 03/30/2012 |
Decision Date | 01/11/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|