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FDA 510(k)

GALIX GBI -3S-LP

K-Number: K992706 · 2001-03-15

ApplicantGalix Biomedical Instrumentation, Inc.
Decision Date2001-03-15
Product CodeMLO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GALIX GBI -3S-LP is the device name listed in this FDA 510(k) record. The listed applicant is Galix Biomedical Instrumentation, Inc.. It received FDA 510(k) clearance on 2001-03-15 under 510(k) number K992706. The device is classified under product code MLO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALIX GBI -3S-LP?

GALIX GBI -3S-LP is a medical device that received FDA 510(k) clearance on 2001-03-15. The listed applicant is Galix Biomedical Instrumentation, Inc.. The 510(k) number is K992706.

When did GALIX GBI -3S-LP receive FDA 510(k) clearance?

GALIX GBI -3S-LP received FDA 510(k) clearance on 2001-03-15, under 510(k) number K992706.

Who is the listed applicant for GALIX GBI -3S-LP?

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

What is the FDA product code for GALIX GBI -3S-LP?

The FDA product code for GALIX GBI -3S-LP is MLO.

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Other records listing Galix Biomedical Instrumentation, Inc. as applicant

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Related Devices (Code: MLO)

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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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