510(k) K852502

AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849 by Bruel & Kjaer Industri A/S — Product Code IYO

K852502 is an FDA 510(k) premarket notification submitted by Bruel & Kjaer Industri A/S for the device "AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849". The FDA issued a decision of Substantially Equivalent on October 23, 1986. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Bruel & Kjaer Industri A/S has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1986
Date Received
June 12, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type