LFF — Unit, Activation, Breath Control Class I

FDA Device Classification

FDA product code LFF covers "Unit, Activation, Breath Control", a Class I medical device regulated under 21 CFR 890.3920. Submissions are reviewed by the Physical Medicine panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
LFF
Device Class
Class I
Regulation Number
890.3920
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K964977interactive living systemsIVOC- INTEGRATED VOICE OPERATED CONTROL UNIT (IVOC-1)August 31, 1998