Device Classification Name |
Cuff, Tracheal Tube, Inflatable
|
510(k) Number |
K150893 |
Device Name |
IntelliCuff |
Applicant |
HAMILTON MEDICAL AG |
VIA CRUSCH 8 |
BONADUZ,
CH
7402
|
|
Applicant Contact |
STEFFEN BODEN |
Correspondent |
HAMILTON MEDICAL AG |
VIA CRUSCH 8 |
BONADUZ,
CH
7402
|
|
Correspondent Contact |
STEFFEN BODEN |
Regulation Number | 868.5750
|
Classification Product Code |
|
Date Received | 04/02/2015 |
Decision Date | 01/29/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|