MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM


the company

Device Classification Name

system, x-ray, angiographic

510(k) Number K002840
Device Name MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM
Original Applicant
THE PHANTOM LABORATORY, INC.
2727 state route 29
greenwich, 
NY 
12834

Original Contact joshua r levy
Regulation Number 892.1600
Classification Product Code
IZI  
Date Received 09/12/2000
Decision Date 11/17/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No