Marks Reference Phantom, Measure Reference Phantom

FDA 510(k) K002840 · The Phantom Laboratory, Inc.

Substantially Equivalent

510(k) numberK002840

Submission

Device name
Marks Reference Phantom, Measure Reference Phantom
Applicant
The Phantom Laboratory, Inc.
Greenwich, NY, US
Received
September 12, 2000
Decision date
November 17, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IZI – System, X-Ray, Angiographic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1600
Specialty
Radiology

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Questions and answers

When was Marks Reference Phantom, Measure Reference Phantom cleared by the FDA?

Marks Reference Phantom, Measure Reference Phantom (K002840) received a 510(k) decision of Substantially Equivalent on November 17, 2000, 66 days after the submission was received.

What is the product code of K002840?

The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.