Medical Device Manufacturer · SG , Singapore

Bioptimal International Pte. , Ltd.

1 submissions · 1 cleared · Since 2025
1
Total
1
Cleared
0
Denied

Bioptimal International Pte. , Ltd. — FDA 510(k) Submissions

Bioptimal International Pte. , Ltd. has submitted 1 FDA 510(k) premarket notifications since 2025, of which 1 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrode, Pacemaker, Temporary . Use the specialty filter in the sidebar to narrow results.

1 devices
1–1 of 1
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All1 Cardiovascular 1