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510(k) K040461

ECONOLITH E3000, MODEL 3000 (SW-6) by Medispec, Ltd. — Product Code LNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2004
Date Received
February 23, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Extracorporeal Shock-Wave, Urological
Device Class
Class II
Regulation Number
876.5990
Review Panel
GU
Submission Type

Other clearances by Medispec, Ltd.

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  • K063504 — ECONOLITH EM1000 (March 9, 2007)
  • K974796 — LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER (March 12, 1998)

Other clearances for product code LNS

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  • K242922 — Extracorporeal Shock Wave Lithotripter (U200) (June 18, 2025)
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  • K213772 — LM-9300 Plus Lithotripter (January 19, 2023)
  • K201001 — Modulith SLX-F2 (March 30, 2021)
  • K201074 — Delta III Lithotripter (September 3, 2020)
  • K172084 — Delta III Lithotripter (August 8, 2017)
  • K170122 — Delta III Lithotripter (June 28, 2017)
  • K151298 — Gemini XXP-HP (July 30, 2015)
  • K142561 — LM-9300 ELMA Lithotripter (March 20, 2015)