510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OUMClass I

Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation

21 CFR 886.1050 / Ophthalmic
FDA source (opens on fda.gov)

OUM is the FDA product code for Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation, a class I device type, regulated under 21 CFR 886.1050. FDA's definition for this code reads: "Measurement of retinal adaptation (regeneration of the visual purple) and absolute visible sensitivity to light". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OUM
Device name
Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation
FDA definition
Measurement of retinal adaptation (regeneration of the visual purple) and absolute visible sensitivity to light.
Regulation
21 CFR 886.1050
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code OUM

By decision year
1 clearance under product code OUM with a decision year between 2011 and 2011, 2011 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OUM by decision year
YearClearances
20111

Applicants with the most clearances

Product code OUM
Applicants holding the most 510(k) clearances under product code OUM
ApplicantClearances
Apeliotus Vision Science, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code