Model 3000C Caloric Irrigator
FDA 510(k) K813552 · Life-Tech Intl., Inc.
510(k) numberK813552
Submission
- Device name
- Model 3000C Caloric Irrigator
- Applicant
- Life-Tech Intl., Inc.
Walker, MI, US - Received
- December 21, 1981
- Decision date
- February 22, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ETP – Stimulator, Caloric-Water
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.1800
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code ETP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K863615 | Enthermo Irrigation UnitETP · Traditional | Jedmed Instrument Co. | 12/16/1986SE |
| K820775 | VestibularisetETP · Traditional | Jedmed Instrument Co. | 11/03/1982SE |
| K821481 | Nasal-Throat Spray Irrigation Instrum.ETP · Traditional | Ethicare Products | 06/14/1982SE |
| K800443 | HygrothermETP · Traditional | Jedmed Instrument Co. | 03/10/1980SE |
| K800442 | VariothermETP · Traditional | Jedmed Instrument Co. | 03/10/1980SE |
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| K954315 | PVC Abdominal/Rectal Pressure CatheterFEN · Traditional | 11/30/1995SE |
| K954341 | Urodynamics Tubing and Infusion SetsFEN · Traditional | 10/17/1995SE |
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| K953353 | Urovision JanusFEN · Traditional | 09/08/1995SE |
| K946108 | Ear-A-GatorKHH · Traditional | 06/13/1995SE |
| K913601 | MicrophorEGJ · Traditional | 07/15/1994SE |
| K940203 | Triple Lumen Urodynamic Catheter with Radiopaque MarkersFEN · Traditional | 03/30/1994SE |
Questions and answers
When was Model 3000C Caloric Irrigator cleared by the FDA?
Model 3000C Caloric Irrigator (K813552) received a 510(k) decision of Substantially Equivalent on February 22, 1982, 63 days after the submission was received.
What is the product code of K813552?
The FDA product code is ETP – Stimulator, Caloric-Water, a Class I (low risk) device regulated under 21 CFR 874.1800.