Device Classification Name |
heater, breathing system w/wo controller (not humidifier or nebulizer
|
510(k) Number |
K151959 |
Device Name |
AirLife Infant Single Limb Heated Wire Circuit |
Applicant |
CAREFUSION INC |
75 N FAIRWAY DRIVE |
VERNON HILLS,
IL
60061
|
|
Applicant Contact |
ERIKA FERNANDEZ |
Correspondent |
CAREFUSION INC |
75 N FAIRWAY DRIVE |
VERNON HILLS,
IL
60061
|
|
Correspondent Contact |
ERIKA FERNANDEZ |
Regulation Number | 868.5270
|
Classification Product Code |
|
Date Received | 07/16/2015 |
Decision Date | 01/20/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|