IBP / PHASEIN AB / CBS / Philips Medical System Edan Instruments Inc / Edan Instruments Inc. / FB 121 K113623 Trade / K100939 Colin Medical Instruments Corp / ZOLL Medical Corporation / /
Country
China / /
Currency
pence / GBP / /
Event
FDA Phase / Product Issues / / /
IndustryTerm
gas analyzer / announcements concerning your device / predicate device / manufacturing practice requirements / Internet address http /
MedicalCondition
Arrhythmia / I Arrhythmia / /
Organization
Division of Postmarket Surveillance / Device Evaluation Center for Devices and Radiological Health Patient Monitor Traditional 510OK Submission Section / Food and Drug Administration / CDRH' s office of Surveillance / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / FDA / Cardiovascular Devices Office / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Division of Cardiovascular Devices / /
Person
Silver Spring / Randy Jiang / Enclosure Zuckerman / / /
Position
ramn D. Director Division / physician / Certification Engineer / /
Product
Enflurane / Halothane / Federal Food / electrodes / /
k113&1 )L3FEB[removed]Patient Monitor Traditional 510OK Submission Section 1