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

Pupillometer, Manual

21 CFR 886.1700 / Ophthalmic
FDA source (opens on fda.gov)

HLH is the FDA product code for Pupillometer, Manual, a class I device type, regulated under 21 CFR 886.1700. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HLH
Device name
Pupillometer, Manual
Regulation
21 CFR 886.1700
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 HLH

By decision year
2 clearances under product code HLH with a decision year between 1982 and 1982, 1982 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HLH by decision year
YearClearances
19822

Applicants with the most clearances

Product code HLH
Applicants holding the most 510(k) clearances under product code HLH
ApplicantClearances
Medical Equipment Designs, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order