Medical Device Manufacturer · AU , Surry Hills

Headsafe Mfg Pty, Ltd. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2023
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Headsafe Mfg Pty, Ltd. Neurology ✕
2 devices
1-2 of 2
Cleared Mar 27, 2025
Nurochek-Pro System
K243426 · PIW
Neurology · 143d
Cleared Dec 27, 2023
Nurochek-II System
K231914 · PIW
Neurology · 181d
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