Device Classification Name |
incubator, neonatal transport
|
510(k) Number |
K161918 |
Device Name |
SREE MRI Transport Incubator |
Applicant |
ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS |
PO BOX 603220 |
CLEVELAND,
OH
44103
|
|
Applicant Contact |
RAVI SRINIVASAN |
Correspondent |
ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS |
PO BOX 603220 |
CLEVELAND,
OH
44103
|
|
Correspondent Contact |
RAVI SRINIVASAN |
Regulation Number | 880.5410
|
Classification Product Code |
|
Date Received | 07/13/2016 |
Decision Date | 03/03/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|