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Manufacturers
US
Aeye Health, Inc.
Medical Device Manufacturer
·
US , New York , NY
Aeye Health, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2022
Recent clearances:
AEYE-DS
,
AEYE-DS
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Aeye Health, Inc.
Ophthalmic
✕
2
devices
1-2 of 2
Filters
Cleared
CT
Apr 23, 2024
AEYE-DS
K240058
·
PIB
Ophthalmic
·
106d
Cleared
CT
Nov 10, 2022
AEYE-DS
K221183
·
PIB
Ophthalmic
·
199d
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Ophthalmic
2