Medical Device Manufacturer · US , Rocklin , CA

Ortho8, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2021
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ortho8, Inc. Cardiovascular ✕
3 devices
1-3 of 3
Cleared Jun 03, 2022
CIRCUL8 Connect DVT Prevention Device
K220761 · JOW
Cardiovascular · 80d
Cleared Nov 15, 2021
Circul8 Pro
K212731 · JOW
Cardiovascular · 77d
Cleared Sep 08, 2021
CIRCUL8 Luxe DVT Prevention Device
K211235 · JOW
Cardiovascular · 135d
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