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FDA 510(k)

BRAVO PH MONITORING SYSTEM AND ACCESSORIES

K-Number: K102543 · 2010-12-01

ApplicantGiven Imaging , Ltd.
Decision Date2010-12-01
Product CodeFFT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BRAVO PH MONITORING SYSTEM AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Given Imaging , Ltd.. It received FDA 510(k) clearance on 2010-12-01 under 510(k) number K102543. 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 AND ACCESSORIES?

BRAVO PH MONITORING SYSTEM AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2010-12-01. The listed applicant is Given Imaging , Ltd.. The 510(k) number is K102543.

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

BRAVO PH MONITORING SYSTEM AND ACCESSORIES received FDA 510(k) clearance on 2010-12-01, under 510(k) number K102543.

Who is the listed applicant for BRAVO PH MONITORING SYSTEM AND ACCESSORIES?

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

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

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

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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.

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.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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