CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR)— 510(k) K902460

Name: FDA 510(k) clearance K902460
Creator: U.S. Food and Drug Administration
Published: 1990-08-28

Substantially Equivalent

Oakfield Instruments, Ltd.

FDA 510(k) clearance K902460 for CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR), Substantially Equivalent on 1990-08-28. Applicant: Oakfield Instruments, Ltd.. Device class: 1.

Clearance details

Applicant: Oakfield Instruments, Ltd.
Product code: Code IZD
Device class: Class 1
Regulation: 21 CFR 892.1320
Advisory panel: Radiology
Date received: 1990-06-04
Decision date: 1990-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxon Ox8 1ja England, GB

Download summary PDF View on FDA.gov ↗

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