510(k) K921426

ULTRA PCI by Advanced Medical Products, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1992
Date Received
March 24, 1992
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