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510(k) K842024

Device
ULTRASONIC LITHOTRIPTOR 300A
Applicant
FIBRA SONICS, INC.
510(k) number
K842024
Product code
FEO  
Decision
Substantially Equivalent (SESE)
Decision date
1984-12-11
Date received
1984-05-18
Regulation
876.4480
Classification name
Lithotriptor, Ultrasonic
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KIRCHSCHLAGER
Address
5312 N. Elston Ave. Chicago IL US 60630 60630

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FEO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K230893Swiss LthoClast TrilogyE.M.S Electro Medical Systems S.A2023-10-23
K182490Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A2018-10-09
K181997Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A2018-08-30
K181364Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A2018-06-20
K173234Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A2018-01-10
K171024ShockPulse-SE Lithotripsy SystemCybersonics, Inc.2017-08-21
K142428Shock Pulse-SE Lithotripsy System CYBERWAND IICybersonics, Inc.2014-11-13
K993046FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000Fibra Sonics, Inc.1999-11-22
K973251KSEA CALCUSONKARL STORZ Endoscopy-America, Inc.1998-06-22
K920235ULTRASOUND GENERATOR MODLE 2270Richard Wolf Medical Instruments Corp.1992-12-07
K873367OLYMPUS LUS ULTRASONIC LITHOTRIPTEROlympus Corp.1987-11-30
K850298ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEMCabot Medical Corp.1985-03-05
K843101KARL STORZ 27086KC ULTRASONIC LITHOTRIKARL STORZ Endoscopy-America, Inc.1984-12-11

Legacy Summary#

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FDA Review#

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