Recognized standard
S3.39:1987 (Reaffirmed 2020)
FDA recognition 4-90 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-90 |
|---|---|
| Designation | S3.39:1987 (Reaffirmed 2020) |
| Title | American National Standard Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance) |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Aug 6, 2013 |
| Device classes | Class 2 |
| Scope (excerpt) | The instruments covered by this standard are designed primarily for the measurement of acoustic impedance, acoustic admittance, or both quantities, within the human external auditory meatus. The standard is concerned with the parameters and tolerances of instruments used for measurement of aural… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
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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: