EAR-A-GATOR
FDA 510(k) clearance K946108 · decided 1995-06-13
Clearance details
- K-number
- K946108
- Device name
- EAR-A-GATOR
- Applicant
- Life-Tech Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-12-14
- Decision date
- 1995-06-13
- Days to decision
- 181 days
- Clearance type
- Traditional
- Product code
- KHH
- Device class
- 1
- Regulation number
- 874.1800
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HORTMANN AIRMATIC AIR CALORIC STIMULATOR (K950785) | Jedmed Instrument Co. | 1995-06-28 |
| WATER IRRIGATOR, W1 200 (K941325) | Strong Medical, Inc. | 1994-08-09 |
| NCA-200 (K931608) | Ics Medical Corp. | 1993-06-22 |
| AUTOMATIC CALORIC IRRIGATION SYSTEM (K925237) | Ics Medical Corp. | 1993-05-05 |
| AUTOMATIC CALORIC IRRIGATION SYSTEM (K881630) | Ics Medical Corp. | 1988-06-21 |
| FRENZEL EYEGLASSES & RELATED ITEMS (K822179) | Kelleher Corp. | 1982-09-21 |
Recalls involving this device
No recalls on record reference this clearance.