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510(k) K980363

ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI) by Orofacial Dynamics — Product Code LBB

K980363 is an FDA 510(k) premarket notification submitted by Orofacial Dynamics for the device "ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI)". The FDA issued a decision of Substantially Equivalent on April 16, 1998. The device falls under product code LBB (Dynamometer, Ac-Powered), a Class II device regulated under 21 CFR 888.1240.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1998
Date Received
January 29, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dynamometer, Ac-Powered
Device Class
Class II
Regulation Number
888.1240
Review Panel
NE
Submission Type

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  • K042889 — DYNAMOMETER - MODEL FCE AND MODEL MSC (November 16, 2004)
  • K012492 — KADANCE 2000 (November 2, 2001)
  • K981730 — DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002 (July 17, 1998)
  • K964933 — MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG) (February 3, 1997)
  • K964685 — DYNAMOMETER (January 27, 1997)
  • K935757 — GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM (April 15, 1994)
  • K931321 — CSD 200/300/400/500 DYNAMOMETER (February 15, 1994)

FDA data resources