Ear-A-Gator
FDA 510(k) K946108 · Life-Tech Intl., Inc.
510(k) numberK946108
Submission
- Device name
- Ear-A-Gator
- Applicant
- Life-Tech Intl., Inc.
Houston, TX, US - Received
- December 14, 1994
- Decision date
- June 13, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K881630 | Automatic Caloric Irrigation SystemKHH · Traditional | Ics Medical Corp. | 06/21/1988SE |
| K822179 | Frenzel Eyeglasses & Related ItemsKHH · Traditional | Kelleher Corp. | 09/21/1982SE |
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| 510(k) | Device | Decision |
|---|---|---|
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| K954505 | Ez StimKOI · Traditional | 12/10/1996SE |
| K954315 | PVC Abdominal/Rectal Pressure CatheterFEN · Traditional | 11/30/1995SE |
| K954341 | Urodynamics Tubing and Infusion SetsFEN · Traditional | 10/17/1995SE |
| K953451 | Uropump Tube & Damping ChamgerFEN · Traditional | 10/05/1995SE |
| K953353 | Urovision JanusFEN · Traditional | 09/08/1995SE |
| K913601 | MicrophorEGJ · Traditional | 07/15/1994SE |
| K940203 | Triple Lumen Urodynamic Catheter with Radiopaque MarkersFEN · Traditional | 03/30/1994SE |
| K931179 | Urolab SpectrumFAP · Traditional | 11/18/1993SE |
Questions and answers
When was Ear-A-Gator cleared by the FDA?
Ear-A-Gator (K946108) received a 510(k) decision of Substantially Equivalent on June 13, 1995, 181 days after the submission was received.
What is the product code of K946108?
The FDA product code is KHH – Stimulator, Caloric-Air, a Class I (low risk) device regulated under 21 CFR 874.1800.