510(k) K072075

MODIFICATION TO GE LOGIQ A3 by General Electric Co. — Product Code IYN

K072075 is an FDA 510(k) premarket notification submitted by General Electric Co. for the device "MODIFICATION TO GE LOGIQ A3". The FDA issued a decision of Substantially Equivalent on August 29, 2007. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. General Electric Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2007
Date Received
July 30, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type