| Device Classification Name |
Compressor, Air, Portable
|
| 510(k) Number |
K884722 |
| Device Name |
LUMINEB I |
| Applicant |
| Lumiscope Co., Inc. |
| 400 Raritan Center Pkwy. |
|
Edison,
NJ
08837
|
|
| Applicant Contact |
STEVEN RAY |
| Correspondent |
| Lumiscope Co., Inc. |
| 400 Raritan Center Pkwy. |
|
Edison,
NJ
08837
|
|
| Correspondent Contact |
STEVEN RAY |
| Regulation Number | 868.6250 |
| Classification Product Code |
|
| Date Received | 11/10/1988 |
| Decision Date | 02/03/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|