FLEXILOG 3000— 510(k) K964589

Substantially Equivalent

Oakfield Instruments, Ltd.

FDA 510(k) clearance K964589 for FLEXILOG 3000, Substantially Equivalent on 1997-03-04. 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: 1996-11-15
Decision date: 1997-03-04
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.

K964804 — FLEXILOG LS1997-08-06
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Data sourced from openFDA. This site is unofficial and independent of the FDA.