Medical Device Manufacturer · US , Bridgewater , NJ

Hamamatsu Photonics K.K. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1989
8
Total
8
Cleared
0
Denied

Hamamatsu Photonics K.K. has 8 FDA 510(k) cleared medical devices. Based in Bridgewater, US.

Last cleared in 2023. Active since 1989.

Browse the FDA 510(k) cleared devices submitted by Hamamatsu Photonics K.K. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Hyman, Phelps & McNamara, P.C. as regulatory consultant. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.

FDA 510(k) Regulatory Record - Hamamatsu Photonics K.K.
8 devices
1-8 of 8
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