510(k) K100954
- Device
- ADAPT, MODEL AX-03SN
- Applicant
- APELIOTUS VISION SCIENCE, INC
- 510(k) number
- K100954
- Product code
- OUM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-02-25
- Date received
- 2010-04-07
- Regulation
- 886.1050
- Classification name
- Adaptometer (biophotometer), Software-based Data Acquisition And Stimulus Generation
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN G EDWARDS
- Address
- 1456 N. Morningside Dr. NE Atlanta GA US 30306 30306
FDA Registration Numbers#
- 3008058195
- 3017657497
- 3020954748
- 3004571972
- 3006984486
- 3016500342
- 1221363
- 3004574050
Source Documents#
Legacy Summary#
summary
FDA Review#
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