The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Tof-watch Sx.
| Device ID | K992598 |
| 510k Number | K992598 |
| Device Name: | TOF-WATCH SX |
| Classification | Stimulator, Nerve, Peripheral, Electric |
| Applicant | ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Contact | Rebecca A Rivas |
| Correspondent | Rebecca A Rivas ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Product Code | KOI |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-03 |
| Decision Date | 1999-08-30 |
| Summary: | summary |