Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- OGPCricothyrotomy Kit2Product Code
- OGVTracheostomy Cleaning Tray2Product Code
- OGWTracheostomy Kit2Product Code
- MYBPillow, Cervical (For Mild Sleep Apnea)2Product Code
- EPNPump, Nebulizer, Manual1Product Code
- EPPSplint, Nasal1Product Code
- ETFUnit, Examining/Treatment, Ent1Product Code
- EWTDevice, Antichoke, Suction3Product Code
- EWWDevice, Antichoke, Tongs3Product Code
- JPWPump, Nebulizer, Electrically Powered1Product Code
- KCJApplicator, Ent1Product Code
- KCLBlower, Powder, Ent1Product Code
- KCMDropper, Ent1Product Code
- KCNEar Wick1Product Code
- KCONasal Spray, Ent Delivery1Product Code
- KCPSyringe, Ent1Product Code
- KMAIrrigator, Powered Nasal1Product Code
- KTHDevice, Anti-Stammering1Product Code
- LRDApplicator, Ent Drug1Product Code
- PKAExternal Upper Esophageal Sphincter (Ues) Compression Device2Product Code
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- 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
Device, Anti-Stammering
- Page Type
- Product Code
- Regulation Medical Specialty
- Ear, Nose, Throat
- Review Panel
- Ear, Nose, Throat
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 874.5840
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- 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 § 874.5840 Antistammering device
§ 874.5840 Antistammering device.
(a) Identification. An antistammering device is a device that electronically generates a noise when activated or when it senses the user's speech and that is intended to prevent the user from hearing the sounds of his or her own voice. The device is used to minimize a user's involuntary hesitative or repetitive speech.
(b) 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 § 874.9.
[51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000]