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FDA 510(k)

FLEXILOG LS

K-Number: K964804 · 1997-08-06

ApplicantOakfield Instruments, Ltd.
Decision Date1997-08-06
Product CodeKLA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEXILOG LS is the device name listed in this FDA 510(k) record. The listed applicant is Oakfield Instruments, Ltd.. It received FDA 510(k) clearance on 1997-08-06 under 510(k) number K964804. The device is classified under product code KLA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXILOG LS?

FLEXILOG LS is a medical device that received FDA 510(k) clearance on 1997-08-06. The listed applicant is Oakfield Instruments, Ltd.. The 510(k) number is K964804.

When did FLEXILOG LS receive FDA 510(k) clearance?

FLEXILOG LS received FDA 510(k) clearance on 1997-08-06, under 510(k) number K964804.

Who is the listed applicant for FLEXILOG LS?

The FDA 510(k) record lists Oakfield Instruments, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEXILOG LS?

The FDA product code for FLEXILOG LS is KLA.

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Other records listing Oakfield Instruments, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K964589FLEXILOG 3000K961895FLEXILOG LS 13921K945069FLEXILOG 2000K920115MEDISCINTK902460CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR)K896288FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM

View all 8 devices →

Related Devices (Code: KLA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242666Fecobionics Anorectal SystemGi Bionics, LLCK242304REDNeuraxis, Inc.K234107Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)Laborie Medical Technologies, Corp.K180135THD Anopress with THD SensyProbeThd SpaK161785THD ANOPRESSThd SpaK120088MCOMPASS ANORECTAL MANOMETRY SYSTEMMedspira, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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