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

Anomaloscope

21 CFR 886.1070 / Ophthalmic
FDA source (opens on fda.gov)

HIW is the FDA product code for Anomaloscope, a class I device type, regulated under 21 CFR 886.1070. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HIW
Device name
Anomaloscope
Regulation
21 CFR 886.1070
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
3
Ingested recalls
0

Clearances, product code HIW

By decision year
3 clearances under product code HIW with a decision year between 1986 and 1994, 1986 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HIW by decision year
YearClearances
19861
19911
19941

Applicants with the most clearances

Product code HIW
Applicants holding the most 510(k) clearances under product code HIW
ApplicantClearances
Bova Intl.1
Chromagraphics, Inc.1
LKC Technologies, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code