Cleared Traditional

THD SLIDE

K081429 · Thd Spa · Radiology
Jul 2008
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K081429 is an FDA 510(k) clearance for the THD SLIDE, a Monitor, Ultrasonic, Nonfetal (Class II — Special Controls, product code JAF), submitted by Thd Spa (North Reading, US). The FDA issued a Cleared decision on July 30, 2008, 70 days after receiving the submission on May 21, 2008. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1540.

Submission Details

510(k) Number K081429 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 2008
Decision Date July 30, 2008
Days to Decision 70 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