ARTICULAR HEARING AIDS— 510(k) K964603
Substantially EquivalentDecibel Instruments, Inc.
FDA 510(k) clearance K964603 for ARTICULAR HEARING AIDS, Substantially Equivalent on 1996-12-06. Applicant: Decibel Instruments, Inc.. Device class: 1.
Clearance details
- Applicant
- Decibel Instruments, Inc.
- Product code
- Code ESD
- Device class
- Class 1
- Regulation
- 21 CFR 874.3300
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
Recent devices under product code ESD
view allMore clearances from Decibel Instruments, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.