| Device Classification Name |
System, Reading, Television, Closed-Circuit
|
| 510(k) Number |
K920069 |
| Device Name |
MAGNI-CAM |
| Applicant |
| Innoventions, Inc. |
| 12 Robin Crest Ln. |
|
Ltttleton,
CO
80123
|
|
| Applicant Contact |
EDWARD R BETTINARDI |
| Correspondent |
| Innoventions, Inc. |
| 12 Robin Crest Ln. |
|
Ltttleton,
CO
80123
|
|
| Correspondent Contact |
EDWARD R BETTINARDI |
| Regulation Number | 886.5820 |
| Classification Product Code |
|
| Date Received | 01/07/1992 |
| Decision Date | 03/02/1992 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Ophthalmic
|
| 510k Review Panel |
Ophthalmic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|