Medical Device Manufacturer · US , Ann Arbor , MI

Fifth Eye, Inc. - FDA 510(k) Cleared Devices

3 submissions · 2 cleared · Since 2021
3
Total
2
Cleared
1
Denied

FDA 510(k) cleared devices by Fifth Eye, Inc. Cardiovascular ✕

3 devices
1-3 of 3
Cleared Jul 14, 2022
AHI System
K221203 · QNV
Cardiovascular · 79d
Cleared Dec 03, 2021
AHI System
K212219 · QNV
Cardiovascular · 140d
Not Cleared Mar 01, 2021
Analytic for Hemodynamic Instability (AHI)
DEN200022 · QNV
Cardiovascular · 332d
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