MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT— 510(k) K962228
Substantially EquivalentOtotech Intl., Inc.
FDA 510(k) clearance K962228 for MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT, Substantially Equivalent on 1996-08-28. Applicant: Ototech Intl., Inc.. Device class: 1.
Clearance details
- Applicant
- Ototech Intl., 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
- Oklahoma City, OK, US
Recent devices under product code ESD
view allData sourced from openFDA. This site is unofficial and independent of the FDA.