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510(k) K133781

Device
DECLIPSESPECT LAPAROSCOPY
Applicant
SURGICEYE GMBH
510(k) number
K133781
Product code
IZD  
Decision
Substantially Equivalent (SESE)
Decision date
2014-04-11
Date received
2013-12-12
Regulation
892.1320
Classification name
Probe, Uptake, Nuclear
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MORITZ HOYER
Address
Friedenstrasse 18a Munich, Bavaria DE 81671 81671

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IZD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K123917DECLIPSESPECT VIEWERSurgiceye GmbH2013-01-25
K101887CONFIDENT SURGERY SUITE 300, MODEL CSS300Surgiceye GmbH2011-03-22
K013751HANDHELD GAMMA FINDER (HGF)Silicon Instruments Gmhb2002-02-06
K983768MODIFICATION TO GAMMA GUIDANCE SYSTEMRadiation Monitoring Devices, Inc.1999-07-02
K982442C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)Care Wise Medical Products Corp.1998-08-25
K971167NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIESNeoprobe Corp.1997-06-26
K961321GAMMA GUIDANCE SYSTEMRadiation Monitoring Devices, Inc.1997-02-10
K962319NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIESNeoprobe Corp.1996-09-13
K942580NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIESNeoprobe Corp.1995-02-09
K932153THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROMEBiodan Medical Systems, Ltd.1993-09-07
K930962CAPTUS 2000 WEL COUNTERCapintec Instruments, Inc.1993-05-18
K924586CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWARECapintec Instruments, Inc.1992-12-03
K922117C-TRAK BIOPSY SYSTEMCare Wise Medical Products Corp.1992-10-14
K915279NEOPROBE PORTABLE RADIOSCOPE DETECTORNeoprobe Corp.1992-06-10
K921428CAPTUS 500Capintec Instruments, Inc.1992-05-28

Legacy Summary#

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FDA Review#

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