Recognized standard
S3.13-1987 (Reaffirmed 2020)
FDA recognition 4-165 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-165 |
|---|---|
| Designation | S3.13-1987 (Reaffirmed 2020) |
| Title | American National Standard Mechanical Coupler for Measurement of Bone Vibrators |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Jul 9, 2014 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard specifies requirements for mechanical couplers used for calibrating bone-conduction audi-meters and for making measurements on bone vibrators and bone-conduction hearing aids, in the frequency range from 125 to 8000 hertz (Hz) inclusive. |
At a glance
- None 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: