510(k) K013192

SONICATOR PLUS 930, MODEL ME 930 by Mettler Electronics Corp. — Product Code IMI

K013192 is an FDA 510(k) premarket notification submitted by Mettler Electronics Corp. for the device "SONICATOR PLUS 930, MODEL ME 930". The FDA issued a decision of Substantially Equivalent on October 17, 2001. The device falls under product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5300. Mettler Electronics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2001
Date Received
September 25, 2001
Clearance Type
Abbreviated
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