Device Classification Name |
Cuff, Tracheal Tube, Inflatable
|
510(k) Number |
K202874 |
Device Name |
Puritan Bennett Cuff Pressure Manager |
Applicant |
Covidien llc |
6F, Building 3, 2388 Chenhang Road |
Shanghai,
CN
201114
|
|
Applicant Contact |
Jenny Liu |
Correspondent |
Covidien llc |
6F, Building 3, 2388 Chenhang Road |
Shanghai,
CN
201114
|
|
Correspondent Contact |
Jenny Liu |
Regulation Number | 868.5750
|
Classification Product Code |
|
Date Received | 09/28/2020 |
Decision Date | 01/09/2021 |
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
|
|
|