510(k) K010102

SONIC MODEL SO-300 by Metron Medical Australia, Pty, Ltd. — Product Code IMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2001
Date Received
January 12, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5300
Review Panel
PM
Submission Type