FDA 510(k)

T65 (9016E061-)

K-Number: K252032 · 2025-07-30

Decision Date2025-07-30

Product CodeOBP

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

T65 (9016E061-) is a medical device manufactured by Tonica Elektronik A/S. It received FDA 510(k) clearance on 2025-07-30 under approval number K252032. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T65 (9016E061-)?

T65 (9016E061-) is a medical device that received FDA 510(k) clearance on 2025-07-30. It is manufactured by Tonica Elektronik A/S. The 510(k) number is K252032.

When was T65 (9016E061-) approved by the FDA?

T65 (9016E061-) received FDA 510(k) clearance on 2025-07-30, under approval number K252032.

What company makes T65 (9016E061-)?

T65 (9016E061-) is manufactured by Tonica Elektronik A/S.

What is the FDA product code for T65 (9016E061-)?

The FDA product code for T65 (9016E061-) is OBP.

Other Devices by Tonica Elektronik A/S

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Related Devices (Code: OBP)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.