Device Classification Name |
valve, non-rebreathing
|
510(k) Number |
K173770 |
Device Name |
OJR215 Pressure Relief Manifold |
Applicant |
Fisher & Paykel Healthcare Limited |
15 Maurice Paykel Place, |
East Tamaki |
Auckland,
NZ
2013
|
|
Applicant Contact |
Adele Bindon |
Correspondent |
Fisher & Paykel Healthcare Limited |
15 Maurice Paykel Place, |
East Tamaki |
Auckland,
NZ
2013
|
|
Correspondent Contact |
Adele Bindon |
Regulation Number | 868.5870
|
Classification Product Code |
|
Date Received | 12/11/2017 |
Decision Date | 04/05/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|