ADAPT, MODEL AX-03SN
FDA 510(k) clearance K100954 · decided 2011-02-25
Clearance details
- K-number
- K100954
- Device name
- ADAPT, MODEL AX-03SN
- Applicant
- Apeliotus Vision Science, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-04-07
- Decision date
- 2011-02-25
- Days to decision
- 324 days
- Clearance type
- Traditional
- Product code
- OUM
- Device class
- 1
- Regulation number
- 886.1050
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Atlanta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.