ADAPT, MODEL AX-03SN— 510(k) K100954
Substantially EquivalentApeliotus Vision Science, Inc.
FDA 510(k) clearance K100954 for ADAPT, MODEL AX-03SN, Substantially Equivalent on 2011-02-25. Applicant: Apeliotus Vision Science, Inc.. Device class: 1.
Clearance details
- Applicant
- Apeliotus Vision Science, Inc.
- Product code
- Code OUM
- Device class
- Class 1
- Regulation
- 21 CFR 886.1050
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Atlanta, GA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.