KHHClass I
Stimulator, Caloric-Air
21 CFR 874.1800 / Ear, Nose, Throat
KHH is the FDA product code for Stimulator, Caloric-Air, a class I device type, regulated under 21 CFR 874.1800. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- KHH
- Device name
- Stimulator, Caloric-Air
- Regulation
- 21 CFR 874.1800
- Device class
- Class I
- Review panel
- Ear, Nose, Throat
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 7
- Ingested recalls
- 0
Clearances, product code KHH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1988 | 1 |
| 1993 | 2 |
| 1994 | 1 |
| 1995 | 2 |
Applicants with the most clearances
Product code KHH| Applicant | Clearances |
|---|---|
| Ics Medical Corp. | 3 |
| JEDMED Instrument Company | 1 |
| Kelleher Corp. | 1 |
| Life-Tech Intl., Inc. | 1 |
| Strong Medical, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Aspen Surgical Products, Inc.
- Atmos Inc.
- Atmos Medizintechnik GmbH & Co. KG
- DGS Diagnostics Sp. z o.o
- Hermann Medizintechnik GmbH
- Industrias Apson S.A de C.V
- Interacoustics a/S
- Isen Tech.&trading Co., Ltd.
- Natus Manufacturing Limited
- Natus Medical Denmark ApS
- Natus Sensory Ireland Ltd
- S.A. Instrumentation Difra
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
