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510(k) K181997

Swiss LithoClast Trilogy by E.M.S Electro Medical Systems S.A — Product Code FEO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2018
Date Received
July 26, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Ultrasonic
Device Class
Class II
Regulation Number
876.4480
Review Panel
GU
Submission Type

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Other clearances for product code FEO

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  • K173234 — Swiss LithoClast Trilogy (January 10, 2018)
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  • K142428 — Shock Pulse-SE Lithotripsy System CYBERWAND II (November 13, 2014)
  • K993046 — FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 (November 22, 1999)
  • K973251 — KSEA CALCUSON (June 22, 1998)
  • K920235 — ULTRASOUND GENERATOR MODLE 2270 (December 7, 1992)
  • K873367 — OLYMPUS LUS ULTRASONIC LITHOTRIPTER (November 30, 1987)