510(k) K862029

SIEMENS RADIOTHERM 706, MICROWAVE THERAPY UNIT by Elmed, Inc. — Product Code IOA

K862029 is an FDA 510(k) premarket notification submitted by Elmed, Inc. for the device "SIEMENS RADIOTHERM 706, MICROWAVE THERAPY UNIT". The FDA issued a decision of Substantially Equivalent on July 16, 1986. The device falls under product code IOA (Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5275. Elmed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1986
Date Received
May 28, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5275
Review Panel
PM
Submission Type