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Cranial Sound Monitor

Page Type
Product Code
Definition
To non-invasively detect, monitor, record and display acoustic signals in the brain.
Physical State
Acoustic recording hardware and signal processing software. The device may include a headset to be placed in the ear. The device may include hardware and software to allow for data collection and review. The device does not include software that outputs any clinical interpretation of the data.
Technical Method
An audio recorder headphone is placed into the ear to detect acoustic sounds of the brain / cranium, which are transmitted to hardware that processes and displays these sounds.
Target Area
Head
Regulation Medical Specialty
Cardiovascular
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.1875
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
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]

Cranial Sound Monitor

Page Type
Product Code
Definition
To non-invasively detect, monitor, record and display acoustic signals in the brain.
Physical State
Acoustic recording hardware and signal processing software. The device may include a headset to be placed in the ear. The device may include hardware and software to allow for data collection and review. The device does not include software that outputs any clinical interpretation of the data.
Technical Method
An audio recorder headphone is placed into the ear to detect acoustic sounds of the brain / cranium, which are transmitted to hardware that processes and displays these sounds.
Target Area
Head
Regulation Medical Specialty
Cardiovascular
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.1875
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
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]