The following data is part of a premarket notification filed by Bomed Inc with the FDA for Tebco-w.
| Device ID | K132892 |
| 510k Number | K132892 |
| Device Name: | TEBCO-W |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | BOMED INC 59-440 PILI PL. Kamuela, HI 96743 |
| Contact | B. Bo Sramek, Ph.d |
| Correspondent | B. Bo Sramek, Ph.d BOMED INC 59-440 PILI PL. Kamuela, HI 96743 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-16 |
| Decision Date | 2014-08-01 |