Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- MOFGuide, Wire, Catheter, Neurovasculature2Product Code
- NDQSystem, Catheter Or Guidewire, Steerable (Magnetic)2Product Code
- NRYCatheter, Thrombus Retriever2Product Code
- NUIUltrasound, Infusion, System2Product Code
- QBECranial Sound Monitor2Product Code
- QJPCatheter, Percutaneous, Neurovasculature2Product Code
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
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
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
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]