FDA 510(k)

Intraoperative Ultrasound Probe Cover

K-Number: K222460 · 2023-05-12

Decision Date2023-05-12

Product CodeITX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Intraoperative Ultrasound Probe Cover is a medical device manufactured by Exact Medical Manufacturing. It received FDA 510(k) clearance on 2023-05-12 under approval number K222460. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intraoperative Ultrasound Probe Cover?

Intraoperative Ultrasound Probe Cover is a medical device that received FDA 510(k) clearance on 2023-05-12. It is manufactured by Exact Medical Manufacturing. The 510(k) number is K222460.

When was Intraoperative Ultrasound Probe Cover approved by the FDA?

Intraoperative Ultrasound Probe Cover received FDA 510(k) clearance on 2023-05-12, under approval number K222460.

What company makes Intraoperative Ultrasound Probe Cover?

Intraoperative Ultrasound Probe Cover is manufactured by Exact Medical Manufacturing.

What is the FDA product code for Intraoperative Ultrasound Probe Cover?

The FDA product code for Intraoperative Ultrasound Probe Cover is ITX.

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Related Devices (Code: ITX)

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Official Source

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