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510(k) K120171

ACCUSONIC ADVANTAGE by Metron Medical Australia, Pty, Ltd. — Product Code IMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2012
Date Received
January 20, 2012
Clearance Type
Special
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

Other clearances by Metron Medical Australia, Pty, Ltd.

  • K132137 — MULTISTIM (September 12, 2013)
  • K124010 — ACCUSONIC ADVANTAGE (August 23, 2013)
  • K030880 — VECTORSONIC, MODEL VU-270 (April 18, 2003)
  • K030878 — ACCOUSONIC, MODEL AS-270 (March 28, 2003)
  • K030648 — VECTORSURGE 5 MODEL 470 (March 28, 2003)
  • K030410 — ACCOUSONIC PLUS, MODEL AP-170 (February 20, 2003)
  • K020119 — VECTORSONIC, MODEL VU-200 (July 22, 2002)
  • K011955 — MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 (July 16, 2001)
  • K001897 — MULTI-STIM, MODEL MS-100 (June 12, 2001)
  • K002058 — VECTORSURGE 5, MODEL VS-500 (May 29, 2001)

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