The following data is part of a premarket notification filed by Sigma with the FDA for Smart Adjuster (sa201).
| Device ID | K962239 |
| 510k Number | K962239 |
| Device Name: | SMART ADJUSTER (SA201) |
| Classification | Manipulator, Plunger-like Joint |
| Applicant | SIGMA 175 WILLIAM PITT WAY Pittsburgh, PA 15238 |
| Contact | Tamas Becse |
| Correspondent | Tamas Becse SIGMA 175 WILLIAM PITT WAY Pittsburgh, PA 15238 |
| Product Code | LXM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-11 |
| Decision Date | 1997-01-10 |
| Summary: | summary |