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FDA 510(k)

FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM

K-Number: K896288 · 1990-05-04

ApplicantOakfield Instruments, Ltd.
Decision Date1990-05-04
Product CodeFFT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM 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 1990-05-04 under 510(k) number K896288. 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 1010 AMBULATORY PH MONITORING SYSTEM?

FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1990-05-04. The listed applicant is Oakfield Instruments, Ltd.. The 510(k) number is K896288.

When did FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM receive FDA 510(k) clearance?

FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM received FDA 510(k) clearance on 1990-05-04, under 510(k) number K896288.

Who is the listed applicant for FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM?

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 1010 AMBULATORY PH MONITORING SYSTEM?

The FDA product code for FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM 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 13921K945069FLEXILOG 2000K920115MEDISCINTK902460CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR)

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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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