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FDA 510(k)

BRAVO PH MONITORING SYSTEM

K-Number: K002028 · 2000-09-29

ApplicantEndonetics, Inc.
Decision Date2000-09-29
Product CodeFFT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BRAVO PH MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Endonetics, Inc.. It received FDA 510(k) clearance on 2000-09-29 under 510(k) number K002028. 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 BRAVO PH MONITORING SYSTEM?

BRAVO PH MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2000-09-29. The listed applicant is Endonetics, Inc.. The 510(k) number is K002028.

When did BRAVO PH MONITORING SYSTEM receive FDA 510(k) clearance?

BRAVO PH MONITORING SYSTEM received FDA 510(k) clearance on 2000-09-29, under 510(k) number K002028.

Who is the listed applicant for BRAVO PH MONITORING SYSTEM?

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

What is the FDA product code for BRAVO PH MONITORING SYSTEM?

The FDA product code for BRAVO PH MONITORING SYSTEM is FFT.

Related Clinical Trials

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.

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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.K961346PH ANALYSIS MODULESynectics-DantecK950087LOT 440Medical Instruments Corporation Mic AGK955018TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATORInstrumentarium Corp.K945069FLEXILOG 2000Oakfield Instruments, Ltd.

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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