FLEXILOG LS— 510(k) K964804

Substantially Equivalent

Oakfield Instruments, Ltd.

FDA 510(k) clearance K964804 for FLEXILOG LS, Substantially Equivalent on 1997-08-06. Applicant: Oakfield Instruments, Ltd.. Device class: 2.

Clearance details

Applicant: Oakfield Instruments, Ltd.
Product code: Code KLA
Device class: Class 2
Regulation: 21 CFR 876.1725
Advisory panel: Gastroenterology, Urology
Date received: 1996-11-29
Decision date: 1997-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxon Ox8 1ja England, GB

Download summary PDF View on FDA.gov ↗

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More clearances from Oakfield Instruments, Ltd.

K964589 — FLEXILOG 30001997-03-04
K961895 — FLEXILOG LS 139211996-11-04
K945069 — FLEXILOG 20001995-06-13
K920115 — MEDISCINT1992-03-30
K902460 — CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR)1990-08-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.