Cleared Special

THD SLIDE ONE

K090009 · Thd Spa · Radiology

Jan 2009

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K090009 is an FDA 510(k) clearance for the THD SLIDE ONE, 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 January 28, 2009, 26 days after receiving the submission on January 2, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1540.

Submission Details

510(k) Number	K090009 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 02, 2009
Decision Date	January 28, 2009
Days to Decision	26 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF