Device Classification Name |
Valve, Non-Rebreathing
|
510(k) Number |
K082345 |
Device Name |
OXYGEN DEMAND VALVE |
Applicant |
BPR MEDICAL, LTD. |
22, HAMILTON WAY |
MANSFIELD, NOTTINGHAMSHIRE,
GB
NG18 5BU
|
|
Applicant Contact |
BEN JOHNSON |
Correspondent |
BPR MEDICAL, LTD. |
22, HAMILTON WAY |
MANSFIELD, NOTTINGHAMSHIRE,
GB
NG18 5BU
|
|
Correspondent Contact |
BEN JOHNSON |
Regulation Number | 868.5870
|
Classification Product Code |
|
Date Received | 08/15/2008 |
Decision Date | 03/13/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|