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

Rack, Skiascopic

21 CFR 886.1750 / Ophthalmic
FDA source (opens on fda.gov)

HMH is the FDA product code for Rack, Skiascopic, a class I device type, regulated under 21 CFR 886.1750. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HMH
Device name
Rack, Skiascopic
Regulation
21 CFR 886.1750
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
2
Ingested recalls
0

Clearances, product code HMH

By decision year
2 clearances under product code HMH with a decision year between 1984 and 1985, 1984 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HMH by decision year
YearClearances
19841
19851

Applicants with the most clearances

Product code HMH
Applicants holding the most 510(k) clearances under product code HMH
ApplicantClearances
Luneau Laboratories1
Visitec Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code