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

Collimator, X-Ray

21 CFR 872.1840 / Dental
FDA source (opens on fda.gov)

EHB is the FDA product code for Collimator, X-Ray, a class I device type, regulated under 21 CFR 872.1840. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EHB
Device name
Collimator, X-Ray
Regulation
21 CFR 872.1840
Device class
Class I
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code EHB

By decision year
5 clearances under product code EHB with a decision year between 1978 and 1992, 1984 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code EHB by decision year
YearClearances
19781
19842
19901
19921

Applicants with the most clearances

Product code EHB
Applicants holding the most 510(k) clearances under product code EHB
ApplicantClearances
General X-Ray, Inc.1
Innovators, Inc.1
Knochen Dental Laboratory1
Moyco Industries, Inc.1
S.C.D.P.I. of Florida, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code