510(k) K070931

MODEL PMT850 by Promedtek, Inc. — Product Code ILX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2007
Date Received
April 3, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5290
Review Panel
PM
Submission Type