FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD
K Number: K861019
·
Decision Apr 2, 1986
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
6
Applicant Total
1
Review Days
15
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
- CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD
- K Number
- K861019
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.6500
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Phase One Disign Co.
- Date Received
- March 18, 1986
- Decision Date
- April 2, 1986
- Product Code
- EAK
- Advisory Committee
- Radiology
- 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 |
|---|---|---|---|
| EAK | Screen, Leaded, Operator Radiation Protector | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EAK), ordered by most recent decision date.
CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628
FDA 510(k)
FDA Class 1
·Radiology
ED CORP RADIATION SCREEN
FDA 510(k)
FDA Class 1
·Radiology
MULTIPLE ED1600 SERIES RADIATION SHIELDS
FDA 510(k)
FDA Class 1
·Radiology
MOBILE X-RAY PERSONNEL PROTECTIVE SCREENS
FDA 510(k)
FDA Class 1
·Radiology
LEAD PLASTIC VIEWING PANELS
FDA 510(k)
FDA Class 1
·Radiology
MODULAR X-RAY BARRIERS
FDA 510(k)
FDA Class 1
·Radiology