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510(k) K173234

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2018
Date Received
October 5, 2017
Clearance Type
Traditional
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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  • 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)