OQQ — Diagnostic Ultrasonic Transducer, Robotic Class II

FDA Device Classification

FDA product code OQQ covers "Diagnostic Ultrasonic Transducer, Robotic", a Class II medical device regulated under 21 CFR 892.1570. Submissions are reviewed by the Radiology panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
OQQ
Device Class
Class II
Regulation Number
892.1570
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Definition

Diagnostic ultrasonic imaging or monitoring.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K092164shenzhen delicate electronics coTRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UMay 13, 2010