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 |