Kl40899 Trade / Halo Medical Technologies / EMC / Conclusions Halo Medical Technologies / Preparation Date Halo Medical Technologies LLC / In Vitro Diagnostics / DE 19810 Jennifer L. Kinney / / /
EntertainmentAwardEvent
the cine / /
Event
FDA Phase / /
Facility
lDrug Adinistrajion Document Control Center / / /
IndustryTerm
eāā / equivalent device / predicate device / manufacturing practice requirements / real-time ultrasonic ultrasonic images / singleapplication ultrasound imaging system / manufacturing practice / search existing data sources / pulsed echo imaging system / Mechanical sector ultrasound imaging / subject device / sector ultrasound imaging probe / energy source / software/firmware documentation / electronics / software~based parameter controls / marketed predicate devices / annoulncements concerning your device / /
MedicalCondition
Aneurysms / disorders / /
Organization
Mark Job Responsible Third Party / Division of Postmarket Surveillance / Division of Industry and Consumer Education / Division of Indus'try and Consumer Education / Food and Drug Administration office of Chief Information officer Paperwork Reduction Act / Radiological Health Center for Devices and Radiological Health Enclosure / Center for Devices / Setvice Food and lDrug Adinistrajion Document Control Center / Center for Devices and Radiological Health / Radiological Health / FDA / CDRH 's office of Surveillance / An / Department of Health and Human Services / /
Person
Mark Job / Janine M. Morris / Pediatric Intravascular / Suite G Wilmington / / /
Position
Vice President of Marketing and Regulatory Affairs Telephone / Director Division / Official / /
Product
Requirements / Ultrasound System Transducer Probes / Federal Food / K070907 / /
ProgrammingLanguage
EC / /
Technology
radiation / Universal Serial Bus / Ultrasound / http / Ultrasound System / /
51 0(k) Premarket NotificationMA05 14 i/