Device Classification Name |
Gas-Machine, Anesthesia
|
510(k) Number |
K844008 |
Device Name |
PENLON AM1000 ANAESTHESIA MACHINE |
Applicant |
PENLON, INC. |
ABINGDON |
OX14 3PH |
ENGLAND,
GB
|
|
Correspondent |
PENLON, INC. |
ABINGDON |
OX14 3PH |
ENGLAND,
GB
|
|
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 10/12/1984 |
Decision Date | 03/12/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|