FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ED CORP RADIATION SCREEN
K Number: K944445
·
Decision May 11, 1995
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
6
Applicant Total
1
Review Days
241
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Basic Information
- Device Name
- ED CORP RADIATION SCREEN
- K Number
- K944445
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.6500
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Med Corp.
- Date Received
- September 12, 1994
- Decision Date
- May 11, 1995
- 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 |
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