The following data is part of a premarket notification filed by G.f. S.r.l. with the FDA for Thd.
| Device ID | K070815 |
| 510k Number | K070815 |
| Device Name: | THD |
| Classification | Monitor, Ultrasonic, Nonfetal |
| Applicant | G.F. S.R.L. 5 TIMBER LANE North Reading, MA 01864 |
| Contact | Maureen O'connell |
| Correspondent | Maureen O'connell G.F. S.R.L. 5 TIMBER LANE North Reading, MA 01864 |
| Product Code | JAF |
| CFR Regulation Number | 892.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-26 |
| Decision Date | 2007-06-20 |
| Summary: | summary |