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FDA 510(k)

ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI)

K-Number: K980363 · 1998-04-16

ApplicantOrofacial Dynamics
Decision Date1998-04-16
Product CodeLBB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI) is the device name listed in this FDA 510(k) record. The listed applicant is Orofacial Dynamics. It received FDA 510(k) clearance on 1998-04-16 under 510(k) number K980363. The device is classified under product code LBB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI)?

ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI) is a medical device that received FDA 510(k) clearance on 1998-04-16. The listed applicant is Orofacial Dynamics. The 510(k) number is K980363.

When did ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI) receive FDA 510(k) clearance?

ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI) received FDA 510(k) clearance on 1998-04-16, under 510(k) number K980363.

Who is the listed applicant for ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI)?

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

What is the FDA product code for ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI)?

The FDA product code for ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI) is LBB.

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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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