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510(k) K130513

Device
VOLISTA 400; VOLISTA 600
Applicant
MAQUET SAS
510(k) number
K130513
Product code
FTD  
Decision
Substantially Equivalent (SESE)
Decision date
2013-05-08
Date received
2013-02-27
Regulation
878.4580
Classification name
Lamp, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
TOSIN YEDESS
Address
45 Barbour Pond Dr. Wayne NJ US 07470 07470

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FTD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K133425SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHTEngineered Medical Solutions Co., LLC2013-12-05
K123776POLARIS 100/200Drager Medical GmbH2013-03-08
K111020ATRICURE DISSECTORAtriCure, Inc.2011-06-09
K100234HM-LAMP IIHillusa, Inc.2010-07-08
K100884STRYKER KNIFELIGHTHowmedica Osteonics Corp.2010-06-25
K071180SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001Engineered Medical Solutions Co., LLC2007-06-20
K053364HALUX IRIS EXAMINATION AND SURGICAL LAMPWaldmann Lighting2006-02-23
K041681ATRICURE DISSECTORAtriCure, Inc.2004-07-01
K013242AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEMSTERIS Corporation2001-12-13
K010724SOLA 700,SOLA 500, SOLA 300Drager Medizintechnik GmbH2001-06-07
K003423ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055St. Francis Medical Equipment Co., Ltd.2001-02-22
K981717STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTORStryker Instruments1998-06-30
K961122STRYKER KNIFELIGHTStryker Instruments1996-08-22
K954263XE-LITEOphthalmic Technologies, Inc.1995-10-18
K942553GENESISBurton Medical Products Corp.1994-06-23

Legacy Summary#

summary

FDA Review#

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