Cleared Traditional

THD

K070815 · G.F. S.R.L. · Radiology
Jun 2007
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K070815 is an FDA 510(k) clearance for the THD, a Monitor, Ultrasonic, Nonfetal (Class II — Special Controls, product code JAF), submitted by G.F. S.R.L. (North Reading, US). The FDA issued a Cleared decision on June 20, 2007, 86 days after receiving the submission on March 26, 2007. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1540.

Submission Details

510(k) Number K070815 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2007
Decision Date June 20, 2007
Days to Decision 86 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAF — Monitor, Ultrasonic, Nonfetal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1540