| Device Classification Name |
Device, Sensing, Optical Contour
|
| 510(k) Number |
K923792 |
| Device Name |
QUANTEC SPINAL MEASUEMENT SYSTEM |
| Applicant |
| Quantec Image Processing , Ltd. |
| 37 King Rd. |
|
Madison,
NJ
07940
|
|
| Applicant Contact |
BRUCE D GROVES |
| Correspondent |
| Quantec Image Processing , Ltd. |
| 37 King Rd. |
|
Madison,
NJ
07940
|
|
| Correspondent Contact |
BRUCE D GROVES |
| Classification Product Code |
|
| Date Received | 07/28/1992 |
| Decision Date | 04/20/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|