pre1976 predicate devices / chemical formulation / noninvasive blood pressure measurement systems / radiation-emitting products / stainless steel / Web/CDRH/ home page / unidentified device / x-ray systems / ophthalmic devices / certain radiology devices / marketed devices / metal components / marketed device / /
MedicalTreatment
radiation / /
Organization
U.S. Department of Health And Human Services / Food and Drug Administration / Radiological Health office of Device Evaluation / office of Device Evaluation / Food and Drug Administration Center for Devices / FDA / /
Person
Heather Rosecrans / / /
Position
supervisor / Director The Division / immediate supervisor and the Division Director / Director / the Division / decision making official / /
Use of Standards in Substantial Equivalence Determinations