HYGROTHERM
FDA 510(k) clearance K800443 · decided 1980-03-10
Clearance details
- K-number
- K800443
- Device name
- HYGROTHERM
- Applicant
- Jedmed Instrument Co.
- Decision
- Substantially Equivalent
- Date received
- 1980-02-28
- Decision date
- 1980-03-10
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- ETP
- Device class
- 1
- Regulation number
- 874.1800
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Mchenry, IL, 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 |
|---|---|---|
| ENTHERMO IRRIGATION UNIT (K863615) | Jedmed Instrument Co. | 1986-12-16 |
| VESTIBULARISET (K820775) | Jedmed Instrument Co. | 1982-11-03 |
| NASAL-THROAT SPRAY IRRIGATION INSTRUM. (K821481) | Ethicare Products | 1982-06-14 |
| MODEL 3000C CALORIC IRRIGATOR (K813552) | Life-Tech Intl., Inc. | 1982-02-22 |
| VARIOTHERM (K800442) | Jedmed Instrument Co. | 1980-03-10 |
Recalls involving this device
No recalls on record reference this clearance.