ETF · Unit, Examining/Treatment, Ent
Ear, Nose, Throat · 21 CFR 874.5300 · Class 1
Overview
| Product Code | ETF |
|---|---|
| Device Name | Unit, Examining/Treatment, Ent |
| Regulation | 21 CFR 874.5300 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
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 | JEDMED SPECTRUM ENT CABINET | Jedmed Instrument Co. | Aug 11, 1995 | SESE |
| K945395 | PREMIER MIRROR WARMER | Premier Dental Products Co. | Jan 18, 1995 | SESE |
| K932470 | LANGGASSE 90 | Happersberger Otopront GmbH | Aug 25, 1993 | SESE |
| K911901 | MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE | Stortz | Jul 26, 1991 | SESE |
| K910781 | #491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES | Midmark Corp. | May 15, 1991 | SESE |
| K910243 | MOBILE TREATMENT CART | Jedmed Instrument Co. | Apr 17, 1991 | SESE |
| K896298 | JEDMED S CHAIR | Jedmed Instrument Co. | Jan 26, 1990 | SESE |
| K896273 | SYSTEMA ENT CABINET | Jedmed Instrument Co. | Jan 26, 1990 | SESE |
| K881958 | JEDMED MAXIM ENT CABINET | Jedmed Instrument Co. | Jul 15, 1988 | SESE |
| K860940 | MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT | Micromedics, Inc. | May 2, 1986 | SESE |
| K855021 | LARYNGEAL MIRROR PRE-WARMER | Jedmed Instrument Co. | Mar 20, 1986 | SESE |
| K843046 | RELIANCE TREATMENT CABINET | F. & F. Koenigkramer | Sep 27, 1984 | SESE |
| K833882 | INSTRUMENT CABINET | Jedmed Instrument Co. | Jan 27, 1984 | SESE |
| K823226 | SN-100 DOCTOR'S ROUND | Kells Medical, Inc. | Nov 22, 1982 | SESE |
| K822252 | ENT TREATMENT UNITS | Kelleher Corp. | Nov 22, 1982 | SESE |
| K822531 | MULTIPLE, ENT CABINET #448 | Midmark Corp. | Sep 28, 1982 | SESE |
| K822530 | MULTIPLE, ENT CHAIR #418 | Midmark Corp. | Sep 14, 1982 | SESE |
| K822016 | NAGASHIMA SN-SP UNIT AND CHAIR | Kelleher Corp. | Sep 14, 1982 | SESE |
| K813490 | VERSION OF A CLOSED-FLOW SYS. CALORIC | Thomas M. Foti, M.D. | Jan 7, 1982 | SESE |
| K810148 | 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
