Device Classification Name |
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
|
510(k) Number |
K160540 |
Device Name |
FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM |
Applicant |
FLEXICARE MEDICAL LIMITED |
CYNON VALLEY BUSINESS PARK |
MOUNTAIN ASH,
GB
CF45 4ER
|
|
Applicant Contact |
JOEL BIDDLE |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 868.5270
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/26/2016 |
Decision Date | 06/23/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|