510(k) K990339

SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O by Hewlett-Packard Co. — Product Code IYN

K990339 is an FDA 510(k) premarket notification submitted by Hewlett-Packard Co. for the device "SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O". The FDA issued a decision of Substantially Equivalent on February 18, 1999. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Hewlett-Packard Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1999
Date Received
February 3, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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