← FDA Medical Device Classifications
Chamber, Acoustic (For Audiometric Testing)
EWC · Class I — Low Risk (general controls) · Ear, Nose, Throat · 21 CFR 874.1060
Classification
- FDA Product Code
EWC- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 874.1060
- Review panel
- EN
- Medical specialty
- Ear, Nose, Throat
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Market data
- Cleared 510(k) submissions
- 2
- Registered establishments
- 1
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown