Cardioscint (Left Ventricular Function Monitor)
FDA 510(k) K902460 · Oakfield Instruments, Ltd.
510(k) numberK902460
Submission
- Device name
- Cardioscint (Left Ventricular Function Monitor)
- Applicant
- Oakfield Instruments, Ltd.
Oxon Ox8 1ja England, GB - Received
- June 4, 1990
- Decision date
- August 28, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Cardioscint (Left Ventricular Function Monitor) cleared by the FDA?
Cardioscint (Left Ventricular Function Monitor) (K902460) received a 510(k) decision of Substantially Equivalent on August 28, 1990, 85 days after the submission was received.
What is the product code of K902460?
The FDA product code is IZD – Probe, Uptake, Nuclear, a Class I (low risk) device regulated under 21 CFR 892.1320.