HMJ — Screen, Tangent, Projection, Battery-Powered Class I

FDA Device Classification

FDA product code HMJ covers "Screen, Tangent, Projection, Battery-Powered", a Class I medical device regulated under 21 CFR 886.1810. Submissions are reviewed by the Ophthalmic panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HMJ
Device Class
Class I
Regulation Number
886.1810
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K934084bioentericsBIOENTERICS ENDOLUMINA ILLUMINATING BOUGIEDecember 16, 1993
K924753bioentericsBIOENTRICS ENDOLUMINA ILLUMINATED BOUGIEDecember 15, 1992