Device Classification Name |
Vaporizer, Anesthesia, Non-Heated
|
510(k) Number |
K942545 |
Device Name |
SIGMA ELITE |
Applicant |
PENLON LTD. |
ABINGDON OX 14 3PH |
ABINGDON OX,
GB
|
|
Applicant Contact |
A. C GREEN |
Correspondent |
PENLON LTD. |
ABINGDON OX 14 3PH |
ABINGDON OX,
GB
|
|
Correspondent Contact |
A. C GREEN |
Regulation Number | 868.5880
|
Classification Product Code |
|
Date Received | 05/31/1994 |
Decision Date | 02/03/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|