Device Classification Name |
humidifier, respiratory gas, (direct patient interface)
|
510(k) Number |
K141940 |
Device Name |
CONCHASMART COLUMN |
Applicant |
TELEFLEX, INC. |
2917 WECK DR. |
RESEARCH TRIANGLE PARK,
NC
27709
|
|
Applicant Contact |
Amanda Webb |
Correspondent |
TELEFLEX, INC. |
2917 WECK DR. |
RESEARCH TRIANGLE PARK,
NC
27709
|
|
Correspondent Contact |
Amanda Webb |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 07/17/2014 |
Decision Date | 11/24/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|