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

Chair, Ophthalmic, Ac-Powered

21 CFR 886.1140 / Ophthalmic
FDA source (opens on fda.gov)

HME is the FDA product code for Chair, Ophthalmic, Ac-Powered, a class I device type, regulated under 21 CFR 886.1140. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HME
Device name
Chair, Ophthalmic, Ac-Powered
Regulation
21 CFR 886.1140
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
16
Ingested recalls
1

Clearances, product code HME

By decision year
16 clearances under product code HME with a decision year between 1978 and 1993, 1985 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code HME by decision year
YearClearances
19781
19801
19842
19854
19864
19871
19891
19921
19931

Applicants with the most clearances

Product code HME
Applicants holding the most 510(k) clearances under product code HME
ApplicantClearances
F. & F. Koenigkramer3
Koken Mfg Company, Inc.2
American Optical Corp.1
Charles D. Bell, Inc.1
Icor AB1
Marco Ophthalmic, Inc.1
Haag-Streit USA Inc1
Sds Dental, Inc.1
Storz Instrument Co.1
Surgical Mechanical Research, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 33 companies shown, in name order