Recognized standard
S3.6-2025
FDA recognition 4-350 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-350 |
|---|---|
| Designation | S3.6-2025 |
| Title | American National Standard Specification for Audiometers |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | The audiometers covered in this specification are devices designed for use in determining the hearing threshold level of an individual in comparison with a chosen standard reference threshold level. This standard provides specifications and tolerances for pure tone, speech, and masking signals and… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: