Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart F — Therapeutic Devices](/submissions/EN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 874.5300](/submissions/EN/subpart-f%E2%80%94therapeutic-devices/874.5300) → ETF — Unit, Examining/Treatment, Ent # ETF · Unit, Examining/Treatment, Ent _Ear, Nose, Throat · 21 CFR 874.5300 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF ## Overview - **Product Code:** ETF - **Device Name:** Unit, Examining/Treatment, Ent - **Regulation:** [21 CFR 874.5300](/submissions/EN/subpart-f%E2%80%94therapeutic-devices/874.5300) - **Device Class:** 1 - **Review Panel:** [Ear, Nose, Throat](/submissions/EN) ## 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. ## Classification Rationale 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. ## Recent Cleared Devices (20 of 32) Showing 20 most recent of 32 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K953457](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF/K953457.md) | JEDMED SPECTRUM ENT CABINET | Jedmed Instrument Co. | Aug 11, 1995 | SESE | | [K945395](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF/K945395.md) | PREMIER MIRROR WARMER | Premier Dental Products Co. | Jan 18, 1995 | SESE | | [K932470](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF/K932470.md) | LANGGASSE 90 | Happersberger Otopront GmbH | Aug 25, 1993 | SESE | | [K911901](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF/K911901.md) | MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE | Stortz | Jul 26, 1991 | SESE | | [K910781](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF/K910781.md) | #491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES | Midmark Corp. | May 15, 1991 | SESE | | [K910243](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF/K910243.md) | MOBILE TREATMENT CART | Jedmed Instrument Co. | Apr 17, 1991 | SESE | | [K896298](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF/K896298.md) | JEDMED S CHAIR | Jedmed Instrument Co. | Jan 26, 1990 | SESE | | [K896273](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF/K896273.md) | SYSTEMA ENT CABINET | Jedmed Instrument Co. | Jan 26, 1990 | SESE | | [K881958](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF/K881958.md) | JEDMED MAXIM ENT CABINET | Jedmed Instrument Co. | Jul 15, 1988 | SESE | | [K860940](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF/K860940.md) | MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT | Micromedics, Inc. | May 2, 1986 | SESE | | [K855021](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF/K855021.md) | LARYNGEAL MIRROR PRE-WARMER | Jedmed Instrument Co. | Mar 20, 1986 | SESE | | [K843046](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF/K843046.md) | RELIANCE TREATMENT CABINET | F. & F. Koenigkramer | Sep 27, 1984 | SESE | | [K833882](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF/K833882.md) | INSTRUMENT CABINET | Jedmed Instrument Co. | Jan 27, 1984 | SESE | | [K823226](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF/K823226.md) | SN-100 DOCTOR'S ROUND | Kells Medical, Inc. | Nov 22, 1982 | SESE | | [K822252](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF/K822252.md) | ENT TREATMENT UNITS | Kelleher Corp. | Nov 22, 1982 | SESE | | [K822531](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF/K822531.md) | MULTIPLE, ENT CABINET #448 | Midmark Corp. | Sep 28, 1982 | SESE | | [K822530](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF/K822530.md) | MULTIPLE, ENT CHAIR #418 | Midmark Corp. | Sep 14, 1982 | SESE | | [K822016](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF/K822016.md) | NAGASHIMA SN-SP UNIT AND CHAIR | Kelleher Corp. | Sep 14, 1982 | SESE | | [K813490](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF/K813490.md) | VERSION OF A CLOSED-FLOW SYS. CALORIC | Thomas M. Foti, M.D. | Jan 7, 1982 | SESE | | [K810148](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF/K810148.md) | ATMOSET | Jedmed Instrument Co. | Feb 17, 1981 | SESE | ## Top Applicants - Jedmed Instrument Co. — 17 clearances - Midmark Corp. — 3 clearances - Kelleher Corp. — 2 clearances - Amsco Co. — 1 clearance - Dunrich, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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