HJT — Haploscope Class I

FDA Device Classification

FDA product code HJT covers "Haploscope", a Class I medical device regulated under 21 CFR 886.1340. 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
HJT
Device Class
Class I
Regulation Number
886.1340
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K013110optical diagnosticsANISEIKONIA INSPECTORDecember 19, 2001
K012530neurovisionAA-1 SYSTEMAugust 31, 2001