FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CEHPALOMETRIC HEAD POSITIONER
K Number: K840275
·
Decision Mar 16, 1984
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
2
Review Days
53
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
- CEHPALOMETRIC HEAD POSITIONER
- K Number
- K840275
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.1850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Gary E. Hall, Dds
- Date Received
- January 23, 1984
- Decision Date
- March 16, 1984
- Product Code
- EAH
- Advisory Committee
- Dental
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| EAH | Cone, Radiographic, Lead-Lined | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EAH), ordered by most recent decision date.
View allOther Clearances by Gary E. Hall, Dds
| K Number | Device Name | ||
|---|---|---|---|
| K864527 | DUOCEPH | Jan 7, 1987 | Substantially Equivalent |