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Medical emergencies / Cardiology / Medical equipment / Medical monitor / Defibrillation / Transcutaneous pacing / Artificial cardiac pacemaker / Cardiopulmonary resuscitation / Ventricular tachycardia / Medicine / Cardiac electrophysiology / Cardiac dysrhythmia


Section 2 - Summary and Certification
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Document Date: 2014-09-23 12:22:33

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File Size: 381,65 KB

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City

Chelmsford / /

Company

IBP / K133484 Trade / Zoll Medical Corp. / ZOLL ZOLL Medical Corporation Worldwide / /

Event

FDA Phase / /

Facility

Mill Road Chelmsford / New Hampshire Avenue Document Control Center / Summary ZOLL ZOLL Medical Corporation Worldwide Headquarters / /

/

IndustryTerm

Web Console features / transportation / portable device / embedded web page / announcements concerning your device / medically-approved patient care protocol / web browser / manufacturing practice requirements / Web Console functionality / marketed predicate devices / manufacturing practice / Internet address http /

MedicalCondition

defibrillator shock / obstructive apnea / heart dysfunction / Unconsciousness / bradycardia / rapid ventricular tachycardia / tachycardia / ventricular fibrillation / apnea episodes / cardiac arrest / apnea monitor / /

MedicalTreatment

CPR / resuscitation / cardioversion / chest compressions / Cardiopulmonary Resuscitation / /

Organization

Division of Postmarket Surveillance / Division of Industry and Consumer Education / Food and Drug Administration / office of Device Evaluation / Cardiovascular Devices Office / Device Evaluation Center for Devices / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / CDRH's office of Surveillance / /

Person

Bram D. Zuckerman / Silver Spring / Ken Skodacek / /

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Position

Tanmay Shukla Regulatory Affairs Specialist / Director Division / Application Correspondent / M.D. Director Division / /

Product

Federal Food / /

ProvinceOrState

Maryland / Massachusetts / /

Technology

Ethernet / radiation / medically-approved patient care protocol / Masimo Rainbow SET technology / /

URL

http /

SocialTag