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FDA 510(k)

ACCUGUIDE MUSCLE INJECTION MONITOR

K-Number: K990793 · 1999-10-22

ApplicantMedtronic Xomed
Decision Date1999-10-22
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ACCUGUIDE MUSCLE INJECTION MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Xomed. It received FDA 510(k) clearance on 1999-10-22 under 510(k) number K990793. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUGUIDE MUSCLE INJECTION MONITOR?

ACCUGUIDE MUSCLE INJECTION MONITOR is a medical device that received FDA 510(k) clearance on 1999-10-22. The listed applicant is Medtronic Xomed. The 510(k) number is K990793.

When did ACCUGUIDE MUSCLE INJECTION MONITOR receive FDA 510(k) clearance?

ACCUGUIDE MUSCLE INJECTION MONITOR received FDA 510(k) clearance on 1999-10-22, under 510(k) number K990793.

Who is the listed applicant for ACCUGUIDE MUSCLE INJECTION MONITOR?

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

What is the FDA product code for ACCUGUIDE MUSCLE INJECTION MONITOR?

The FDA product code for ACCUGUIDE MUSCLE INJECTION MONITOR is GXZ.

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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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