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510(k) K083433

INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 by Chattanooga Group — Product Code IMJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2009
Date Received
November 20, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K031077 — VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM (December 11, 2003)
  • K031116 — VECTRA (INTELECT) EPR ULTRASOUND (December 3, 2003)
  • K023347 — VITAL STIM (December 6, 2002)

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