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FDA 510(k)

FLEXILOG 2000

K-Number: K945069 · 1995-06-13

ApplicantOakfield Instruments, Ltd.
Decision Date1995-06-13
Product CodeFFT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEXILOG 2000 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 1995-06-13 under 510(k) number K945069. The device is classified under product code FFT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXILOG 2000?

FLEXILOG 2000 is a medical device that received FDA 510(k) clearance on 1995-06-13. The listed applicant is Oakfield Instruments, Ltd.. The 510(k) number is K945069.

When did FLEXILOG 2000 receive FDA 510(k) clearance?

FLEXILOG 2000 received FDA 510(k) clearance on 1995-06-13, under 510(k) number K945069.

Who is the listed applicant for FLEXILOG 2000?

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 2000?

The FDA product code for FLEXILOG 2000 is FFT.

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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.

K964804FLEXILOG LSK964589FLEXILOG 3000K961895FLEXILOG LS 13921K920115MEDISCINTK902460CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR)K896288FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM

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Related Devices (Code: FFT)

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.

K102543BRAVO PH MONITORING SYSTEM AND ACCESSORIESGiven Imaging , Ltd.K013951SANDHILL SCIENTIFIC PEDIATEC PH PROBESandhill Scientific, Inc.K002028BRAVO PH MONITORING SYSTEMEndonetics, Inc.K961346PH ANALYSIS MODULESynectics-DantecK950087LOT 440Medical Instruments Corporation Mic AGK955018TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATORInstrumentarium Corp.

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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