Transducer Probe Cover

FDA 510(k) K221278 · Hony Medical Co., Ltd.

Substantially Equivalent

510(k) numberK221278

Submission

Device name
Transducer Probe Cover
Applicant
Hony Medical Co., Ltd.
Taishan, CN
Received
May 3, 2022
Decision date
January 11, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ITX – Transducer, Ultrasonic, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1570
Specialty
Radiology

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More from Vitrolife Sweden AB

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Questions and answers

When was Transducer Probe Cover cleared by the FDA?

Transducer Probe Cover (K221278) received a 510(k) decision of Substantially Equivalent on January 11, 2023, 253 days after the submission was received.

What is the product code of K221278?

The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.