FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EAR-A-GATOR
K Number: K946108
·
Decision Jun 13, 1995
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
6
Applicant Total
68
Review Days
181
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Basic Information
- Device Name
- EAR-A-GATOR
- K Number
- K946108
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.1800
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Life-Tech Intl., Inc.
- Date Received
- December 14, 1994
- Decision Date
- June 13, 1995
- Product Code
- KHH
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KHH | Stimulator, Caloric-Air | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KHH), ordered by most recent decision date.
HORTMANN AIRMATIC AIR CALORIC STIMULATOR
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WATER IRRIGATOR, W1 200
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NCA-200
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AUTOMATIC CALORIC IRRIGATION SYSTEM
FDA 510(k)
FDA Class 1
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AUTOMATIC CALORIC IRRIGATION SYSTEM
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
FRENZEL EYEGLASSES & RELATED ITEMS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Other Clearances by Life-Tech Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K001129 | PROLONG, MODELS PL50, PL100, PL150 | Jul 6, 2000 | Substantially Equivalent |
| K955031 | MAXISTIM | Dec 10, 1996 | Substantially Equivalent |
| K954505 | EZ STIM | Dec 10, 1996 | Substantially Equivalent |
| K954315 | PVC ABDOMINAL/RECTAL PRESSURE CATHETER | Nov 30, 1995 | Substantially Equivalent |
| K954341 | URODYNAMICS TUBING AND INFUSION SETS | Oct 17, 1995 | Substantially Equivalent |
| K953451 | UROPUMP TUBE & DAMPING CHAMGER | Oct 5, 1995 | Substantially Equivalent |
| K953353 | UROVISION JANUS | Sep 8, 1995 | Substantially Equivalent |
| K913601 | MICROPHOR | Jul 15, 1994 | Substantially Equivalent |
| K940203 | TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS | Mar 30, 1994 | Substantially Equivalent |
| K931179 | UROLAB SPECTRUM | Nov 18, 1993 | Substantially Equivalent |