Product code KHH
- Device name
- Stimulator, Caloric-Air
- Medical specialty
- Ear, Nose, Throat
- Device class
- 1
- Regulation number
- 874.1800
- 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 |
|---|---|---|---|
| K950785 | HORTMANN AIRMATIC AIR CALORIC STIMULATOR | Jedmed Instrument Co. | 1995-06-28 |
| K946108 | EAR-A-GATOR | Life-Tech Intl., Inc. | 1995-06-13 |
| K941325 | WATER IRRIGATOR, W1 200 | Strong Medical, Inc. | 1994-08-09 |
| K931608 | NCA-200 | Ics Medical Corp. | 1993-06-22 |
| K925237 | AUTOMATIC CALORIC IRRIGATION SYSTEM | Ics Medical Corp. | 1993-05-05 |
| K881630 | AUTOMATIC CALORIC IRRIGATION SYSTEM | Ics Medical Corp. | 1988-06-21 |
| K822179 | FRENZEL EYEGLASSES & RELATED ITEMS | Kelleher Corp. | 1982-09-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06980291491135 | Air Caloric Irrigator | ISEN Tech. & Trading Co., Ltd. | 2026-07-27 |
| 04250365143065 | ATMOS | ATMOS MedizinTechnik GmbH & Co. KG | 2024-11-27 |
| B516310120 | Instrumentation Difra SA | Instrumentation Difra SA | 2022-09-28 |
| B516310130 | Instrumentation Difra SA | Instrumentation Difra SA | 2022-09-28 |
| 05713315009235 | ICS | Natus Medical Denmark ApS | 2021-07-06 |
| 05713315009242 | ICS | Natus Medical Denmark ApS | 2021-07-06 |
| 05713315009259 | ICS | Natus Medical Denmark ApS | 2021-07-06 |
| 05713315009266 | ICS | Natus Medical Denmark ApS | 2021-07-06 |
| 05711117199567 | Interacoustics | Interacoustics A/S | 2021-06-14 |
| B516174810 | Instrumentation Difra | Instrumentation Difra SA | 2020-05-18 |
| B516175530 | Instrumentation Difra | Instrumentation Difra SA | 2020-05-18 |
| B516174850 | Instrumentation Difra | Instrumentation Difra SA | 2020-05-18 |
| 05713315002533 | GN Otometrics A/S | Natus Medical Denmark ApS | 2019-04-24 |
| B51617481 | Instrumentation Difra | Instrumentation Difra SA | 2018-09-17 |
| B51617485 | Instrumentation Difra | Instrumentation Difra SA | 2018-09-17 |
| B51617553 | Instrumentation Difra | Instrumentation Difra SA | 2018-09-17 |
| 05713315004124 | GN Otometrics A/S | Natus Medical Denmark ApS | 2016-09-19 |
| 05713315004131 | GN Otometrics A/S | Natus Medical Denmark ApS | 2016-09-19 |