AlertWatch Inc. / AlertWatch LLC / Donna-Bea Tillman / Philips / Donna-Bea Tillman Senior Consultant Biologics Consulting Group Inc. / Kl3O4Ol Trade / /
Country
United States / /
Event
FDA Phase / /
Facility
New Hampsbire Avenue Document Control Center / Hospital Re-display / / /
IndustryTerm
anesthesia information management systems / database server / announcements concerning your device / hospital network / software requirements specification / manufacturing practice requirements / installation site / rules/algorithms / marketed predicate devices / Internet address http /
MedicalCondition
arrhythmia / /
NaturalFeature
Sea Tillman / /
Organization
Division of Postmarket Surveillance / Division of Small Manufacturers / office of Device Evaluation / FDA / Cardiovascular Devices Office / Division of Small Manufacturers / International and Consumer Assistance / New Hampsbire Avenue Document Control Center / CDRH's office of Surveillance / Device Evaluation Center for Devices and Radiological Health / /
Person
Brain D. Zuckerman / / /
Position
_____________________________Perfusionist / Live Collector and the Data Collector / Anesthesiologist / Surgeon / Surgeon / Intended Users Anesthesiologist / Director Division / M.D. Director Division / /
K130401 AlertWatch: OR/ FEB 510(k) Summary In accordance with 21 CFR[removed]h) and (21 CFR[removed]the 510(k) Summary for the Alert Watch:OR