| Device Classification Name |
Bed, Scanning, Nuclear
|
| 510(k) Number |
K920962 |
| Device Name |
MULTIPLE ACCESSORY TO GAMMA CAMERAS |
| Applicant |
| Nu Age Products |
| 2271-F Palmdale Blvd., |
| Suite B-38 |
|
Palmdale,
CA
93550
|
|
| Correspondent |
| Nu Age Products |
| 2271-F Palmdale Blvd., |
| Suite B-38 |
|
Palmdale,
CA
93550
|
|
| Regulation Number | 892.1350 |
| Classification Product Code |
|
| Date Received | 02/03/1992 |
| Decision Date | 04/17/1992 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|