FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODEL 3000C CALORIC IRRIGATOR
K Number: K813552
·
Decision Feb 22, 1982
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
5
Applicant Total
68
Review Days
63
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Basic Information
- Device Name
- MODEL 3000C CALORIC IRRIGATOR
- K Number
- K813552
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.1800
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Life-Tech Intl., Inc.
- Date Received
- December 21, 1981
- Decision Date
- February 22, 1982
- Product Code
- ETP
- 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 |
|---|---|---|---|
| ETP | Stimulator, Caloric-Water | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ETP), ordered by most recent decision date.
ENTHERMO IRRIGATION UNIT
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VESTIBULARISET
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NASAL-THROAT SPRAY IRRIGATION INSTRUM.
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HYGROTHERM
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
VARIOTHERM
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
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|---|---|---|---|
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| 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 |
| K946108 | EAR-A-GATOR | Jun 13, 1995 | Substantially Equivalent |
| K913601 | MICROPHOR | Jul 15, 1994 | Substantially Equivalent |
| K940203 | TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS | Mar 30, 1994 | Substantially Equivalent |