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

Set, Audiometer Calibration

21 CFR 874.1080 / Ear, Nose, Throat
FDA source (opens on fda.gov)

EWA is the FDA product code for Set, Audiometer Calibration, a class I device type, regulated under 21 CFR 874.1080. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EWA
Device name
Set, Audiometer Calibration
Regulation
21 CFR 874.1080
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 EWA

By decision year
2 clearances under product code EWA with a decision year between 1978 and 1994, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code EWA by decision year
YearClearances
19781
19941

Applicants with the most clearances

Product code EWA
Applicants holding the most 510(k) clearances under product code EWA
ApplicantClearances
Smith & Nephew Richards, Inc.1
Tracor Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code