ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI)— 510(k) K980363

Name: FDA 510(k) clearance K980363
Creator: U.S. Food and Drug Administration
Published: 1998-04-16

Substantially Equivalent

Orofacial Dynamics

FDA 510(k) clearance K980363 for ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI), Substantially Equivalent on 1998-04-16. Applicant: Orofacial Dynamics. Device class: 2.

Clearance details

Applicant: Orofacial Dynamics
Product code: Code LBB
Device class: Class 2
Regulation: 21 CFR 888.1240
Advisory panel: Orthopedic
Date received: 1998-01-29
Decision date: 1998-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alamo, CA, US

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