Mediscint

FDA 510(k) K920115 · Oakfield Instruments, Ltd.

Substantially Equivalent

510(k) numberK920115

Submission

Device name
Mediscint
Applicant
Oakfield Instruments, Ltd.
Oxon Ox8 1ja England, GB
Received
January 13, 1992
Decision date
March 30, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IZD – Probe, Uptake, Nuclear
Device class
Class I (low risk)
Regulation
21 CFR 892.1320
Specialty
Radiology

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K902460Cardioscint (Left Ventricular Function Monitor)IZD · Traditional 08/28/1990SE
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K894902SourcererJJJ · Traditional 10/17/1989SE

Questions and answers

When was Mediscint cleared by the FDA?

Mediscint (K920115) received a 510(k) decision of Substantially Equivalent on March 30, 1992, 77 days after the submission was received.

What is the product code of K920115?

The FDA product code is IZD – Probe, Uptake, Nuclear, a Class I (low risk) device regulated under 21 CFR 892.1320.