510(k) K220090
- Device
- Visibly Digital Acuity Product
- Applicant
- Visibly, Inc.
- 510(k) number
- K220090
- Product code
- QTO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-08-12
- Date received
- 2022-01-11
- Regulation
- 886.1150
- Classification name
- Digital Visual Acuity Test
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Paul Foley
- Address
- 207 E Ohio St., #233 Chicago IL US 60611 60611
FDA Registration Numbers#
- 3013003882
- 1000431353
- 3005205657
- 3027718329
- 3013532963
- 3043041478
- 3016965632
- 3009155756
- 3013534308
- 1000431825
- 3008197763
- 3017657497
- 3004571972
- 3027396409
- 3031081959
- 3011898560
- 3041277555
- 3013846070
- 3014964775
- 3004574050
- 3013682704
- 3042228518
- 3030641350
- 3007808885
- 3011080538
- 3017784352
- 3014926247
- 3020029799
- 3015392301
- 3003325113
- 3038131813
Source Documents#
Legacy Summary#
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FDA Review#
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