510(k) K874192

MULTIPURPOSE TRANSDUCER RANGE by Pie Data Medical BV — Product Code IYO

K874192 is an FDA 510(k) premarket notification submitted by Pie Data Medical BV for the device "MULTIPURPOSE TRANSDUCER RANGE". The FDA issued a decision of Substantially Equivalent on July 19, 1988. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Pie Data Medical BV has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1988
Date Received
October 14, 1987
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