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

Monitor, Eye Movement, Diagnostic

21 CFR 886.1510 / Ophthalmic
FDA source (opens on fda.gov)

HMC is the FDA product code for Monitor, Eye Movement, Diagnostic, a class II device type, regulated under 21 CFR 886.1510. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
HMC
Device name
Monitor, Eye Movement, Diagnostic
Regulation
21 CFR 886.1510
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code HMC

By decision year
1 clearance under product code HMC with a decision year between 1994 and 1994, 1994 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HMC by decision year
YearClearances
19941

Applicants with the most clearances

Product code HMC
Applicants holding the most 510(k) clearances under product code HMC
ApplicantClearances
Orthomet, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code HMC.