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
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- UnknownReview Panel
Unit, Examining/Treatment, Ent
- 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
- 874.5300
- 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 § 874.5300 Ear, nose, and throat examination and treatment unit
§ 874.5300 Ear, nose, and throat examination and treatment unit.
(a) Identification. An ear, nose, and throat examination and treatment unit is an AC-powered device intended to support a patient during an otologic examination while providing specialized features for examination and treatment. The unit consists of a patient chair and table, drawers for equipment, suction and blowing apparatus, and receptacles for connection of specialized lights and examining instruments.
(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.
[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2316, Jan. 14, 2000]