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Food law / Medical technology / Medical device / Medical equipment / Radiology / Federal Food / Drug / and Cosmetic Act / Center for Devices and Radiological Health / Premarket approval / Title 21 of the Code of Federal Regulations / Medicine / Health / Food and Drug Administration


Interventional Workspot Page 16 of[removed]k) Summary of Safety and Effectiveness
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Document Date: 2013-02-06 08:16:12

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File Size: 146,82 KB

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Company

Philips Medical Systems Nederland B.V. / In Vitro Diagnostics / 90LLZ Legally / Interventional Workspot Trade / K121296 Trade / /

Country

United States / /

Event

FDA Phase / /

Facility

New Hampshire Avenue Document Control Center / /

IndustryTerm

communications system / software platform / announcements concerning your device / medical computer software / software medical devices / manufacturing practice requirements / medical comnputer software / software requirements / marketed predicate devices / software medical device / manufacturing practice / software verification / /

Organization

Radiological Health Office / Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / Radiological Health Center for Devices and Radiological Health Enclosure Indications for Use / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / CDRH's office of Surveillance / /

Person

Janine M.Morris / Janine M.Mdrris / Frans Jacobs / M.Morris - Janine M. Morris / /

/

Position

Director / Division / correspondent / physician / Regulatory Affairs Manager / Manager Telephone / Manager Veenpluis / /

Product

Trade / K031836 -Aug 14 / Federal Food / /

ProvinceOrState

Washington / /

Technology

radiation / http / /

URL

www.fda / http /

SocialTag