Device Classification Name |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
510(k) Number |
K143646 |
FOIA Releasable 510(k) |
K143646
|
Device Name |
MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit |
Applicant |
Fisher & Paykel Healthcare Ltd |
15 Maurice Paykel Place, East Tamaki |
Auckland,
NZ
2013
|
|
Applicant Contact |
Elizabeth Goldstein |
Correspondent |
Fisher & Paykel Healthcare Ltd |
15 Maurice Paykel Place, East Tamaki |
Auckland,
NZ
2013
|
|
Correspondent Contact |
Elizabeth Goldstein |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 12/22/2014 |
Decision Date | 03/05/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|