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FDA 510(k)

T1D1

K-Number: K252104 · 2025-08-20

ApplicantComerge AG
Decision Date2025-08-20
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

T1D1 is a medical device manufactured by Comerge AG. It received FDA 510(k) clearance on 2025-08-20 under approval number K252104. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T1D1?

T1D1 is a medical device that received FDA 510(k) clearance on 2025-08-20. It is manufactured by Comerge AG. The 510(k) number is K252104.

When was T1D1 approved by the FDA?

T1D1 received FDA 510(k) clearance on 2025-08-20, under approval number K252104.

What company makes T1D1?

T1D1 is manufactured by Comerge AG.

What is the FDA product code for T1D1?

The FDA product code for T1D1 is NDC.

Other Devices by Comerge AG

K230195Neo ADVISE software

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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.

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