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FDA 510(k)

WiTOF

K-Number: K243339 · 2025-06-23

ApplicantIdmed
Decision Date2025-06-23
Product CodeKOI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WiTOF is a medical device manufactured by Idmed. It received FDA 510(k) clearance on 2025-06-23 under approval number K243339. The device is classified under product code KOI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WiTOF?

WiTOF is a medical device that received FDA 510(k) clearance on 2025-06-23. It is manufactured by Idmed. The 510(k) number is K243339.

When was WiTOF approved by the FDA?

WiTOF received FDA 510(k) clearance on 2025-06-23, under approval number K243339.

What company makes WiTOF?

WiTOF is manufactured by Idmed.

What is the FDA product code for WiTOF?

The FDA product code for WiTOF is KOI.

Other Devices by Idmed

K172690ToFscan K243562CuffGuard

Related Devices (Code: KOI)

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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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