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510(k) K103813

Device
SOPRO 281
Applicant
SOPRO
510(k) number
K103813
Product code
NTN  
Decision
Substantially Equivalent (SESE)
Decision date
2011-03-22
Date received
2010-12-29
Regulation
876.1500
Classification name
Led Light Source
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RICK ROSATI
Address
124 Gaither Dr. Suite #140 Mt. Laurel NJ US 08054 08054

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NTN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K141164ARTEMIS LIGHT ENGINEQuest Medical Imaging2015-03-16
K133311ENDOLEDOlympus Winter & Ibe GmbH2014-07-30
K130819CLL- V1 LIGHT SOURCEOlympus Winter & Ibe GmbH2013-06-19
K122831VIDEO SYSTEM CENTEROlympus Medical Systems Corp.2012-12-14
K113679LUCEA LED SURGICAL LIGHT SYSTEMMaquet S.A.S.2012-01-12
K102167LO-50 LED LIGHT SOURCEFiberoptics Technology, Inc.2010-08-17
K091829PLS PORTABLE LIGHT SOURCEOptim, Inc.2009-07-28
K090601FSC 2Schoelly Imaging, Inc.2009-05-11

Legacy Summary#

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FDA Review#

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