FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DR. DEDO'S FAMILY EAR EXAMINATION KIT
K Number: K904659
·
Decision Apr 30, 1991
Classifications
1
FEI Numbers
228
Registration Numbers
228
Same Product Code
55
Applicant Total
1
Review Days
197
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
- DR. DEDO'S FAMILY EAR EXAMINATION KIT
- K Number
- K904659
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4770
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Panex Corp.
- Date Received
- October 15, 1990
- Decision Date
- April 30, 1991
- Product Code
- ERA
- 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 |
|---|---|---|---|
| ERA | Otoscope | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ERA), ordered by most recent decision date.
AIO HD OTOSCOPE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
LANTOS 3D EAR SCANNER
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
OSRAM ITOS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
OPTUS OTOSCOPES
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
WELCH ALLYN BI-OTOSCOPE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
WELCH ALLY OTOSCOPE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat