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FDA 510(k)

MYOGUIDE SYSTEM MODEL 8008

K-Number: K111985 · 2011-12-30

ApplicantIntronix Technologies Corp.
Decision Date2011-12-30
Product CodeBXN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MYOGUIDE SYSTEM MODEL 8008 is the device name listed in this FDA 510(k) record. The listed applicant is Intronix Technologies Corp.. It received FDA 510(k) clearance on 2011-12-30 under 510(k) number K111985. The device is classified under product code BXN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYOGUIDE SYSTEM MODEL 8008?

MYOGUIDE SYSTEM MODEL 8008 is a medical device that received FDA 510(k) clearance on 2011-12-30. The listed applicant is Intronix Technologies Corp.. The 510(k) number is K111985.

When did MYOGUIDE SYSTEM MODEL 8008 receive FDA 510(k) clearance?

MYOGUIDE SYSTEM MODEL 8008 received FDA 510(k) clearance on 2011-12-30, under 510(k) number K111985.

Who is the listed applicant for MYOGUIDE SYSTEM MODEL 8008?

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

What is the FDA product code for MYOGUIDE SYSTEM MODEL 8008?

The FDA product code for MYOGUIDE SYSTEM MODEL 8008 is BXN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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