Automatic Caloric Irrigation System
FDA 510(k) K881630 · Ics Medical Corp.
510(k) numberK881630
Submission
- Device name
- Automatic Caloric Irrigation System
- Applicant
- Ics Medical Corp.
Schaumburg, IL, US - Received
- April 14, 1988
- Decision date
- June 21, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KHH – Stimulator, Caloric-Air
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.1800
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code KHH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950785 | Hortmann Airmatic Air Caloric StimulatorKHH · Traditional | Jedmed Instrument Co. | 06/28/1995SE |
| K946108 | Ear-A-GatorKHH · Traditional | Life-Tech Intl., Inc. | 06/13/1995SE |
| K941325 | Water Irrigator, W1 200KHH · Traditional | Strong Medical, Inc. | 08/09/1994SE |
| K931608 | NCA-200KHH · Traditional | Ics Medical Corp. | 06/22/1993SE |
| K925237 | Automatic Caloric Irrigation SystemKHH · Traditional | Ics Medical Corp. | 05/05/1993SE |
| K822179 | Frenzel Eyeglasses & Related ItemsKHH · Traditional | Kelleher Corp. | 09/21/1982SE |
More from Kelleher Corp.
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|---|---|---|
| K031986 | Ics Medical Chartr Ep with Assr and Chartr Oae SystemsEWO · Special | 07/24/2003SE |
| K013060 | Ics Medical Model VG-30 Video GogglesGWN · Traditional | 12/10/2001SE |
| K011181 | Ics Medical Chartr Oae with TympEWO · Traditional | 06/25/2001SE |
| K002985 | Ics Medical Chartr Ep and Chartr Oae SystemsGWJ · Traditional | 12/13/2000SE |
| K991497 | Ics Medical Chartr Eng/Vng Diagnostic SystemGWN · Traditional | 07/28/1999SE |
| K972631 | Ics Medical Vemr Video Eye Movement RecorderGWN · Traditional | 09/22/1997SE |
| K960097 | Chartr EpGWJ · Traditional | 02/21/1997SE |
| K931609 | Chartr Eng SystemGWM · Traditional | 09/26/1995SE |
| K931608 | NCA-200KHH · Traditional | 06/22/1993SE |
| K925237 | Automatic Caloric Irrigation SystemKHH · Traditional | 05/05/1993SE |
Questions and answers
When was Automatic Caloric Irrigation System cleared by the FDA?
Automatic Caloric Irrigation System (K881630) received a 510(k) decision of Substantially Equivalent on June 21, 1988, 68 days after the submission was received.
What is the product code of K881630?
The FDA product code is KHH – Stimulator, Caloric-Air, a Class I (low risk) device regulated under 21 CFR 874.1800.