FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NASAL-THROAT SPRAY IRRIGATION INSTRUM.
K Number: K821481
·
Decision Jun 14, 1982
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
5
Applicant Total
1
Review Days
27
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- NASAL-THROAT SPRAY IRRIGATION INSTRUM.
- K Number
- K821481
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.1800
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Ethicare Products
- Date Received
- May 18, 1982
- Decision Date
- June 14, 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
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
VESTIBULARISET
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
MODEL 3000C CALORIC IRRIGATOR
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
HYGROTHERM
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
VARIOTHERM
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat