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FDA 510(k)

Ultrasound Transducer Cover

K-Number: K241662 · 2024-08-30

ApplicantVitrolife Sweden AB
Decision Date2024-08-30
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ultrasound Transducer Cover is the device name listed in this FDA 510(k) record. The listed applicant is Vitrolife Sweden AB. It received FDA 510(k) clearance on 2024-08-30 under 510(k) 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. The listed applicant is Vitrolife Sweden AB. The 510(k) number is K241662.

When did Ultrasound Transducer Cover receive FDA 510(k) clearance?

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

Who is the listed applicant for Ultrasound Transducer Cover?

The FDA 510(k) record lists Vitrolife Sweden AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultrasound Transducer Cover?

The FDA product code for Ultrasound Transducer Cover is ITX.

Other records listing Vitrolife Sweden AB as applicant

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Related Devices (Code: ITX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.K250883ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)Olympus Medical Systems Corporation

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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