FDA.reportPublic FDA data

510(k) K090601

Device
FSC 2
Applicant
Schoelly Imaging, Inc.
510(k) number
K090601
Product code
NTN
Decision
Substantially Equivalent (SESE)
Decision date
2009-05-11
Date received
2009-03-05
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
F. DAVID ROTHKOPF
Address
100 Hartwell St. West Boylston MA US 01583 01583

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
K103813SOPRO 281Sopro2011-03-22
K102167LO-50 LED LIGHT SOURCEFiberoptics Technology, Inc.2010-08-17
K091829PLS PORTABLE LIGHT SOURCEOptim, Inc.2009-07-28