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

Loupe, Binocular, Low Power

21 CFR 886.5120 / Ophthalmic
FDA source (opens on fda.gov)

HJH is the FDA product code for Loupe, Binocular, Low Power, a class I device type, regulated under 21 CFR 886.5120. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HJH
Device name
Loupe, Binocular, Low Power
Regulation
21 CFR 886.5120
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
3
Ingested recalls
0

Clearances, product code HJH

By decision year
3 clearances under product code HJH with a decision year between 1983 and 1987, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HJH by decision year
YearClearances
19831
19861
19871

Applicants with the most clearances

Product code HJH
Applicants holding the most 510(k) clearances under product code HJH
ApplicantClearances
Almore Intl., Inc.1
Exeter Instruments, Inc.1
Valley Forge Scientific Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 45 companies shown, in name order