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

Chamber, Acoustic (For Audiometric Testing)

21 CFR 874.1060 / Ear, Nose, Throat
FDA source (opens on fda.gov)

EWC is the FDA product code for Chamber, Acoustic (For Audiometric Testing), a class I device type, regulated under 21 CFR 874.1060. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EWC
Device name
Chamber, Acoustic (For Audiometric Testing)
Regulation
21 CFR 874.1060
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
2
Ingested recalls
0

Clearances, product code EWC

By decision year
2 clearances under product code EWC with a decision year between 1982 and 1983, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code EWC by decision year
YearClearances
19821
19831

Applicants with the most clearances

Product code EWC
Applicants holding the most 510(k) clearances under product code EWC
ApplicantClearances
Kelleher Corp.1
Omnicon Medical Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code