| Device Classification Name |
Vaporizer, Anesthesia, Non-Heated
|
| 510(k) Number |
K980489 |
| Device Name |
VAPAMASTA 6 |
| Applicant |
| Medical Industrial Equipment |
| Falcon Rd. Sowton Industrial |
| Estate |
|
Exeter, Devon,
GB
EX2 7NA
|
|
| Applicant Contact |
HENRY MARSHALL |
| Correspondent |
| Medical Industrial Equipment |
| Falcon Rd. Sowton Industrial |
| Estate |
|
Exeter, Devon,
GB
EX2 7NA
|
|
| Correspondent Contact |
HENRY MARSHALL |
| Regulation Number | 868.5880 |
| Classification Product Code |
|
| Date Received | 02/09/1998 |
| Decision Date | 08/31/1998 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|