FDA product code EWC: Chamber, Acoustic (For Audiometric Testing)
EWC is the FDA product code for chamber, acoustic (for audiometric testing). It is a Class I device, regulated under 21 CFR 874.1060 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 2 510(k) submissions under EWC, from 2 different applicants. The average 510(k) review took 34 days (median 34).
Classification
| Field | Value |
|---|---|
| Device name | Chamber, Acoustic (For Audiometric Testing) |
| Device class | Class I |
| Regulation | 21 CFR 874.1060 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EWC clearance
Top EWC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Omnicon Medical Corp. | 1 | 1983-01-21 |
| Kelleher Corp. | 1 | 1982-09-09 |
Most recent EWC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K823872 | Omnicon Medical Corp. | EMERGENCY TRACHEOSTOMY KIT | 1983-01-21 | 25 |
| K822269 | Kelleher Corp. | NAGASHIMA SN SOUND-PROOF CHAMBER-HEARING | 1982-09-09 | 42 |
Recalls for EWC devices
openFDA lists no recalls for product code EWC.
Frequently asked questions
What is FDA product code EWC?
EWC is the FDA product code for chamber, acoustic (for audiometric testing). It is a Class I device, regulated under 21 CFR 874.1060 and reviewed by the Ear, Nose and Throat panel.
What device class is EWC?
Class I, regulation 21 CFR 874.1060. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EWC?
Across 2 cleared submissions the average was 34 days from receipt to decision (median 34).
Which companies have the most EWC clearances?
Omnicon Medical Corp. (1); Kelleher Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EWC
- Run a recall and safety report across every EWC manufacturer
- Watch product code EWC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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