Atlas FDA

CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR)

FDA 510(k) clearance K902460 · decided 1990-08-28

Clearance details

K-number
K902460
Device name
CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR)
Applicant
Oakfield Instruments, Ltd.
Decision
Substantially Equivalent
Date received
1990-06-04
Decision date
1990-08-28
Days to decision
85 days
Clearance type
Traditional
Product code
IZD
Device class
1
Regulation number
892.1320
Medical specialty
Radiology
Advisory committee
Radiology
Location
Oxon Ox8 1ja England, GB
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.