The following data is part of a premarket notification filed by Vickers America Medical Corp. with the FDA for Sp 120 Sophisticate.
| Device ID | K802251 |
| 510k Number | K802251 |
| Device Name: | SP 120 SOPHISTICATE |
| Classification | Calculator/data Processing Module, For Clinical Use |
| Applicant | VICKERS AMERICA MEDICAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JQP |
| CFR Regulation Number | 862.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-16 |
| Decision Date | 1980-10-23 |