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K Number
K955893
Device Name
EVERYTIME TRANSFUCER COVER
Manufacturer
AMEDIC AB
Date Cleared
1997-12-30

(746 days)

Product Code
ITX
Regulation Number
892.1570
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

EVERYTIME™ Transducer Cover

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a device called "EVERYTIMETM Transducer Cover." This letter explicitly states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

However, the letter does not contain any information regarding acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, expert qualifications, or any of the detailed information requested in your prompt.

Therefore, I cannot provide a response with the requested information based solely on this document. This letter is an administrative clearance, not a technical study report.

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.