Device Classification Name |
Vaporizer, Anesthesia, Non-Heated
|
510(k) Number |
K936046 |
Device Name |
SIGMA ELITE |
Applicant |
PENLON, INC. |
ABINGDON |
OX14 3PH |
ENGLAND,
GB
|
|
Applicant Contact |
G.I. WOND |
Correspondent |
PENLON, INC. |
ABINGDON |
OX14 3PH |
ENGLAND,
GB
|
|
Correspondent Contact |
G.I. WOND |
Regulation Number | 868.5880
|
Classification Product Code |
|
Date Received | 12/20/1993 |
Decision Date | 11/04/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|