510(k) K802704

SIAM 80-INSTANTANEOUS SONOGRAPH W/STOR. by Cgr Medical Corp. — Product Code IYO

K802704 is an FDA 510(k) premarket notification submitted by Cgr Medical Corp. for the device "SIAM 80-INSTANTANEOUS SONOGRAPH W/STOR.". The FDA issued a decision of Substantially Equivalent on December 11, 1980. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Cgr Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1980
Date Received
October 31, 1980
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