Device Classification Name |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
510(k) Number |
K162242 |
Device Name |
Comfort Flo Humidification System |
Applicant |
TELEFLEX MEDICAL, INC |
2917 WECK DRIVE |
RESEARCH TRIANGLE PARK,
NC
27709
|
|
Applicant Contact |
BRIAN GALL |
Correspondent |
TELEFLEX MEDICAL, INC |
2917 WECK DRIVE |
RESEARCH TRIANGLE PARK,
NC
27709
|
|
Correspondent Contact |
BRIAN GALL |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 08/10/2016 |
Decision Date | 01/19/2017 |
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
|
|
|