510(k) K872909

SIEMENS SONODYNATOR 834, ULTRASOUND/STIMULATION by Elmed, Inc. — Product Code IMG

K872909 is an FDA 510(k) premarket notification submitted by Elmed, Inc. for the device "SIEMENS SONODYNATOR 834, ULTRASOUND/STIMULATION". The FDA issued a decision of Substantially Equivalent on January 13, 1988. The device falls under product code IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5860. Elmed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1988
Date Received
July 24, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5860
Review Panel
PM
Submission Type