Product code ETF
- Device name
- Unit, Examining/Treatment, Ent
- Medical specialty
- Ear, Nose, Throat
- Device class
- 1
- Regulation number
- 874.5300
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K953457 | JEDMED SPECTRUM ENT CABINET | Jedmed Instrument Co. | 1995-08-11 |
| K945395 | PREMIER MIRROR WARMER | Premier Dental Products Co. | 1995-01-18 |
| K932470 | LANGGASSE 90 | Happersberger Otopront GmbH | 1993-08-25 |
| K911901 | MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE | Stortz | 1991-07-26 |
| K910781 | #491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES | Midmark Corp. | 1991-05-15 |
| K910243 | MOBILE TREATMENT CART | Jedmed Instrument Co. | 1991-04-17 |
| K896273 | SYSTEMA ENT CABINET | Jedmed Instrument Co. | 1990-01-26 |
| K896298 | JEDMED S CHAIR | Jedmed Instrument Co. | 1990-01-26 |
| K881958 | JEDMED MAXIM ENT CABINET | Jedmed Instrument Co. | 1988-07-15 |
| K860940 | MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT | Micromedics, Inc. | 1986-05-02 |
| K855021 | LARYNGEAL MIRROR PRE-WARMER | Jedmed Instrument Co. | 1986-03-20 |
| K843046 | RELIANCE TREATMENT CABINET | F. & F. Koenigkramer | 1984-09-27 |
| K833882 | INSTRUMENT CABINET | Jedmed Instrument Co. | 1984-01-27 |
| K823226 | SN-100 DOCTOR'S ROUND | Kells Medical, Inc. | 1982-11-22 |
| K822252 | ENT TREATMENT UNITS | Kelleher Corp. | 1982-11-22 |
| K822531 | MULTIPLE, ENT CABINET #448 | Midmark Corp. | 1982-09-28 |
| K822530 | MULTIPLE, ENT CHAIR #418 | Midmark Corp. | 1982-09-14 |
| K822016 | NAGASHIMA SN-SP UNIT AND CHAIR | Kelleher Corp. | 1982-09-14 |
| K813490 | VERSION OF A CLOSED-FLOW SYS. CALORIC | Thomas M. Foti, M.D. | 1982-01-07 |
| K810148 | ATMOSET | Jedmed Instrument Co. | 1981-02-17 |
| K802712 | ENTERMED ENTUNIT | Jedmed Instrument Co. | 1980-11-26 |
| K801742 | NEW FINE MODEL ENT TREATMENT UNIT | Jedmed Instrument Co. | 1980-08-13 |
| K801741 | PRETTY MODEL ENT TREATMENT UNIT | Jedmed Instrument Co. | 1980-08-13 |
| K801740 | TREATMENT UNIT FOR DOCTOR'S ROUNDS | Jedmed Instrument Co. | 1980-08-13 |
| K801739 | NOBLE MODEL DOUBLESIDED TREATMENT UNIT | Jedmed Instrument Co. | 1980-08-13 |
| K801738 | NOBLE MEDEL ENT TREATMENT UNIT | Jedmed Instrument Co. | 1980-08-13 |
| K800756 | DUNRICH TABLES | Dunrich, Inc. | 1980-04-16 |
| K800526 | SMR H-CHAIR | Surgical Mechanical Research, Inc. | 1980-03-18 |
| K791936 | ATMOS ENT CABINET PRACTICA 2 | Jedmed Instrument Co. | 1979-10-30 |
| K791935 | ATMOS ENT CABINET PRACTICA 3 | Jedmed Instrument Co. | 1979-10-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| M6330360260 | JEDMED | JEDMED INSTRUMENT COMPANY | 2022-12-16 |
| M6330360300 | JEDMED | JEDMED INSTRUMENT COMPANY | 2022-12-16 |
| M6330360310 | JEDMED | JEDMED INSTRUMENT COMPANY | 2022-12-16 |
| M6330361100 | JEDMED | JEDMED INSTRUMENT COMPANY | 2022-12-16 |
| M633036164L0 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-17 |
| M6330361600 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-17 |
| M633036160L0 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-17 |
| M6330361610 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-17 |
| M633036161L0 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-17 |
| M6330361620 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-17 |
| M633036162L0 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-17 |
| M6330361630 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-17 |
| M633036163L0 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-17 |
| M6330361640 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-17 |
| M633036153L0 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-16 |
| M633036155L0 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-16 |
| M6330361550 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-16 |
| M633036154L0 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-16 |
| M6330361540 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-16 |
| M6330361530 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-16 |
| M633036152L0 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-16 |
| M6330361520 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-16 |
| M633036151L0 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-16 |
| M6330361510 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-16 |
| M633036150L0 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-16 |
| M633036150API10 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-16 |
| M633036150API0 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-16 |
| M6330361500 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-16 |
| M6330360000 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-13 |
| M63303600010 | JEDMED | JEDMED INSTRUMENT COMPANY | 2018-07-13 |