Device Classification Name |
ventilator, emergency, powered (resuscitator)
|
510(k) Number |
K884089 |
Device Name |
ERA 2000 EMERGENCY RESUSCITATOR |
Applicant |
NEOTRONICS MEDICAL LTD. |
PARSONAGE ROAD |
BISHOP'S STORTFORD,
GB
|
|
Applicant Contact |
STAN CHERRY |
Correspondent |
NEOTRONICS MEDICAL LTD. |
PARSONAGE ROAD |
BISHOP'S STORTFORD,
GB
|
|
Correspondent Contact |
STAN CHERRY |
Regulation Number | 868.5925
|
Classification Product Code |
|
Date Received | 09/28/1988 |
Decision Date | 12/20/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|