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

Source, Carrier, Fiberoptic Light

21 CFR 874.4350 / Ear, Nose, Throat
FDA source (opens on fda.gov)

EQH is the FDA product code for Source, Carrier, Fiberoptic Light, a class I device type, regulated under 21 CFR 874.4350. As of , FDA records hold 49 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
EQH
Device name
Source, Carrier, Fiberoptic Light
Regulation
21 CFR 874.4350
Device class
Class I
Review panel
Ear, Nose, Throat
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
49
Ingested recalls
1

Clearances, product code EQH

By decision year
49 clearances under product code EQH with a decision year between 1976 and 1995, 1980 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code EQH by decision year
YearClearances
19761
19809
19811
19827
19832
19841
19861
19873
19903
19916
19925
19931
19946
19953

Applicants with the most clearances

Product code EQH
Applicants holding the most 510(k) clearances under product code EQH
ApplicantClearances
Aspen Laboratories, Inc.10
Kelleher Corp.4
Treace Medical, Inc.4
JEDMED Instrument Company3
Luxtec Corp.3
Gm Engineering, Inc.2
Grieshaber & Co.2
Summit Technology, Inc.2
Surgical Technologies, Inc.2
Applied Fiberoptics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 92 companies shown, in name order