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FDA 510(k)

Ultrasound Transducer Cover

K-Number: K241662 · 2024-08-30

Decision Date2024-08-30
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ultrasound Transducer Cover is a medical device manufactured by Vitrolife Sweden AB. It received FDA 510(k) clearance on 2024-08-30 under approval number K241662. 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 Ultrasound Transducer Cover?

Ultrasound Transducer Cover is a medical device that received FDA 510(k) clearance on 2024-08-30. It is manufactured by Vitrolife Sweden AB. The 510(k) number is K241662.

When was Ultrasound Transducer Cover approved by the FDA?

Ultrasound Transducer Cover received FDA 510(k) clearance on 2024-08-30, under approval number K241662.

What company makes Ultrasound Transducer Cover?

Ultrasound Transducer Cover is manufactured by Vitrolife Sweden AB.

What is the FDA product code for Ultrasound Transducer Cover?

The FDA product code for Ultrasound Transducer Cover is ITX.

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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.