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Lung Sound Monitor

Page Type
Product Code
Definition
The lung sound monitor is intended for use in monitoring and recording lung sounds.
Physical State
The device consists of the arrays of electronic stethoscopes to collect the sound, a digital collector module, and is connected via cable to a PC workstation.
Technical Method
Uses electronic stethoscopes placed in an array on the pts. back to record sounds within 100-250Hz, the sounds recorded are converted from analog to digital, and through software, displayed in a gray-scale image.
Target Area
Posterior thorax to record sounds emanating from the lungs.
Regulation Medical Specialty
Cardiovascular
Review Panel
Anesthesiology
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
870.1875
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 870.1875 Stethoscope

§ 870.1875 Stethoscope.

(a) Manual stethoscope - (1) Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

(2) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

(b) Electronic stethoscope - (1) Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

(2) Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38796, July 25, 2001; 84 FR 71811, Dec. 30, 2019]

Lung Sound Monitor

Page Type
Product Code
Definition
The lung sound monitor is intended for use in monitoring and recording lung sounds.
Physical State
The device consists of the arrays of electronic stethoscopes to collect the sound, a digital collector module, and is connected via cable to a PC workstation.
Technical Method
Uses electronic stethoscopes placed in an array on the pts. back to record sounds within 100-250Hz, the sounds recorded are converted from analog to digital, and through software, displayed in a gray-scale image.
Target Area
Posterior thorax to record sounds emanating from the lungs.
Regulation Medical Specialty
Cardiovascular
Review Panel
Anesthesiology
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
870.1875
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 870.1875 Stethoscope

§ 870.1875 Stethoscope.

(a) Manual stethoscope - (1) Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

(2) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

(b) Electronic stethoscope - (1) Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

(2) Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38796, July 25, 2001; 84 FR 71811, Dec. 30, 2019]