FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RADIOLOGICAL PROTECTIVE EYE SHIELD
K Number: K920540
·
Decision May 28, 1992
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
5
Applicant Total
3
Review Days
113
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Basic Information
- Device Name
- RADIOLOGICAL PROTECTIVE EYE SHIELD
- K Number
- K920540
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.6500
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Burkhart Roentgen Intl., Inc.
- Date Received
- February 5, 1992
- Decision Date
- May 28, 1992
- Product Code
- IWS
- 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 |
|---|---|---|---|
| IWS | Shield, Eye, Radiological | FDA class 1 | Radiology |
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