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

Screen, Leaded, Operator Radiation Protector

21 CFR 892.6500 / Radiology
FDA source (opens on fda.gov)

EAK is the FDA product code for Screen, Leaded, Operator Radiation Protector, a class I device type, regulated under 21 CFR 892.6500. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EAK
Device name
Screen, Leaded, Operator Radiation Protector
Regulation
21 CFR 892.6500
Device class
Class I
Review panel
Radiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
0

Clearances, product code EAK

By decision year
7 clearances under product code EAK with a decision year between 1985 and 1995, 1985 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code EAK by decision year
YearClearances
19852
19861
19901
19941
19952

Applicants with the most clearances

Product code EAK
Applicants holding the most 510(k) clearances under product code EAK
ApplicantClearances
Victoreen, Inc.3
Image Diagnostics, Inc.1
Innovative Products Mfg.1
Med Corp.1
Phase One Disign Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order