Device Classification Name |
cuff, tracheal tube, inflatable
|
510(k) Number |
K191858 |
Device Name |
Pylant Monitor |
Applicant |
Kal-Med LLC |
570 Percival Avenue |
Kensington,
CT
06037
|
|
Applicant Contact |
Sandra Greenwood |
Correspondent |
Kal-Med LLC |
570 Percival Avenue |
Kensington,
CT
06037
|
|
Correspondent Contact |
Sandra Greenwood |
Regulation Number | 868.5750
|
Classification Product Code |
|
Date Received | 07/11/2019 |
Decision Date | 02/24/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|