Device Classification Name |
mixer, breathing gases, anesthesia inhalation
|
510(k) Number |
K943797 |
Device Name |
BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER |
Applicant |
BPR MEDICAL, LTD. |
OAKHAM BUSINESS PARK |
HAMILTON WAY |
MANSFIELD, NOTTS. ENGLAND,
GB
NG18 5BU
|
|
Applicant Contact |
RICHARD D RADFORD |
Correspondent |
BPR MEDICAL, LTD. |
OAKHAM BUSINESS PARK |
HAMILTON WAY |
MANSFIELD, NOTTS. ENGLAND,
GB
NG18 5BU
|
|
Correspondent Contact |
RICHARD D RADFORD |
Regulation Number | 868.5330
|
Classification Product Code |
|
Date Received | 08/03/1994 |
Decision Date | 05/11/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|