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

Distometer

21 CFR 886.1190 / Ophthalmic
FDA source (opens on fda.gov)

HMM is the FDA product code for Distometer, a class I device type, regulated under 21 CFR 886.1190. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HMM
Device name
Distometer
Regulation
21 CFR 886.1190
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code HMM

By decision year
2 clearances under product code HMM with a decision year between 1987 and 1988, 1987 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HMM by decision year
YearClearances
19871
19881

Applicants with the most clearances

Product code HMM
Applicants holding the most 510(k) clearances under product code HMM
ApplicantClearances
Allegheny Plastics, Inc.1
Hagg-Streit Service, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code