EWC · Chamber, Acoustic (For Audiometric Testing)
Ear, Nose, Throat · 21 CFR 874.1060 · Class 1
Overview
| Product Code | EWC |
|---|---|
| Device Name | Chamber, Acoustic (For Audiometric Testing) |
| Regulation | 21 CFR 874.1060 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
Identification
An acoustic chamber for audiometric testing is a room that is intended for use in conducting diagnostic hearing evaluations and that eliminates sound reflections and provides isolation from outside sounds.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K823872 | EMERGENCY TRACHEOSTOMY KIT | Omnicon Medical Corp. | Jan 21, 1983 | SESE |
| K822269 | NAGASHIMA SN SOUND-PROOF CHAMBER-HEARING | Kelleher Corp. | Sep 9, 1982 | SESE |
Top Applicants
- Omnicon Medical Corp. — 1 clearance
- Kelleher Corp. — 1 clearance
