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FDA 510(k)

GO MEDICAL BALLOON INFUSION SYSTEM

K-Number: K000263 · 2000-05-09

ApplicantGo Medical Industries Pty. , Ltd.
Decision Date2000-05-09
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GO MEDICAL BALLOON INFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Go Medical Industries Pty. , Ltd.. It received FDA 510(k) clearance on 2000-05-09 under 510(k) number K000263. The device is classified under product code MEB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GO MEDICAL BALLOON INFUSION SYSTEM?

GO MEDICAL BALLOON INFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2000-05-09. The listed applicant is Go Medical Industries Pty. , Ltd.. The 510(k) number is K000263.

When did GO MEDICAL BALLOON INFUSION SYSTEM receive FDA 510(k) clearance?

GO MEDICAL BALLOON INFUSION SYSTEM received FDA 510(k) clearance on 2000-05-09, under 510(k) number K000263.

Who is the listed applicant for GO MEDICAL BALLOON INFUSION SYSTEM?

The FDA 510(k) record lists Go Medical Industries Pty. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GO MEDICAL BALLOON INFUSION SYSTEM?

The FDA product code for GO MEDICAL BALLOON INFUSION SYSTEM is MEB.

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Related Devices (Code: MEB)

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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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