Device Classification Name |
esophageal thermal regulation and gastric suctioning device
|
De Novo Number |
DEN140018 |
Device Name |
ESOPHAGEAL COOLING DEVICE |
Requester |
advanced cooling therapy, llc |
3440 s dearborn st # 215-south |
chicago,
IL
60616
|
|
Contact |
erik kulstad |
|
Regulation Number | 870.5910
|
Classification Product Code |
|
Date Received | 05/09/2014 |
Decision Date | 06/23/2015 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Cardiovascular
|
Review Advisory Committee |
Cardiovascular
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|