Boston Scientific Corp. / EP Laboratory / 5 V2.6 Software / Submission V2.7 Software / K141185 Trade / LabSystem EP Laboratory / Special 510(k) Submission V237 Software / EMC / V2.6 Software / /
Event
FDA Phase / /
Facility
LabSystem EP Laboratory / / /
IndustryTerm
Internet address http /
OperatingSystem
Windows XP / Microsoft Windows / /
Organization
Division of Postmarket Surveillance / CDR.H's office of Surveillance / Food and Drug Administration / ZuckeraMD Director Division / Cardiovascular Devices Office / Device Evaluation Center for Devices and Radiological Health Enclosure Ki141185 Indications for Use / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / /
Person
Robin M. Mulvey / / /
Position
Vice President / Regulatory Affairs PH / human head / Specialist 11 55 Technology / physician / /
JUN[removed]K141185 Pagel1 of5 510(k) SUMMARY This 51 0(k) Summary is provided per the requirements of section[removed]c).