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510(k) K934846

SONICATOR 716 by Mettler Electronics Corp. — Product Code IMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1994
Date Received
October 8, 1993
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

Other clearances by Mettler Electronics Corp.

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  • K071137 — SONICATOR PLUS 940, MODEL ME940 (August 1, 2007)
  • K053546 — SONICATOR 740, MODEL ME 740 (May 4, 2006)
  • K043586 — LASER SYS*STIM 540, MODEL ME 540 (May 6, 2005)
  • K042554 — AUTO THERM 390, MODEL ME 390 (October 8, 2004)
  • K031017 — SYS*STIM 208 AND 208A (May 30, 2003)
  • K023083 — SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800 (February 28, 2003)
  • K022458 — AUTO*THERM 395, MODEL ME 395 (September 26, 2002)

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  • K150353 — BTL-4000 (November 13, 2015)
  • K120217 — SONICSTIMU COMBO THERAPEUTIC DEVICE (November 21, 2012)
  • K121059 — SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM (August 7, 2012)
  • K102524 — FUTURA (November 3, 2011)
  • K111482 — SONICATOR PLUS 920 (August 25, 2011)
  • K102190 — WINSTIM (March 17, 2011)
  • K092627 — CT2011 SONICSTIMU PAIN RELIEF DEVICE (January 14, 2010)