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speaker-amplifier recorder interface
L&M Ultrascope Life Monitoring Sys.
Summary: The speaker-amplifier recorder interface by L&M Ultrascope is a device used primarily in the monitoring and recording of physiological sounds. It is utilized by healthcare professionals in various clinical settings to enhance acoustic signals for diagnostic purposes.
FDA Clearance Information
Pathway
510K
Number
K780201 ↗
Decision Date
March 2, 1978
Product Code
JAF
Device Class
Class 2
Evidence
0 studies
The speaker-amplifier recorder interface was cleared through the FDA 510k pathway on March 2, 1978. Manufactured by L&M Ultrascope Life Monitoring Sys., it is classified as a Class 2 medical device under product code JAF.
What It Is
This device is designed to amplify and record physiological sounds, such as heartbeats and breath sounds, making them more audible and analyzable for clinicians. It integrates a speaker and amplifier to enhance sound clarity and a recording interface for documentation. Such devices are crucial in diagnostic settings where precise acoustic data is necessary.
Clinical Applications
Commonly used in cardiology and pulmonology, this device aids in the diagnosis of heart and lung conditions by providing clearer audio signals. It is often employed in hospital settings, outpatient clinics, and sometimes in emergency situations where quick and accurate sound assessment is needed. Pediatric and geriatric populations may particularly benefit from its enhanced sound amplification.
Indications for Use
The device is indicated for use in situations where enhanced acoustic monitoring is required, such as in detecting heart murmurs or abnormal lung sounds. It is suitable for patients who need detailed auscultation for diagnostic purposes.
Practical Considerations
The device typically comes in various sizes to accommodate different clinical environments and is compatible with standard auscultation equipment. Users should ensure proper calibration for optimal performance and may require training for effective use.
Frequently Asked Questions
What is the speaker-amplifier recorder interface used for?
It is used for amplifying and recording physiological sounds to aid in the diagnosis of heart and lung conditions.
What specialties typically use this device?
Cardiology and pulmonology specialties frequently use this device, along with general practitioners in various clinical settings.
What are the FDA-cleared indications?
The device is indicated for enhancing and recording physiological sounds for diagnostic purposes in patients with potential heart or lung conditions.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.