FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RADIOGRAPHIC GRID
K Number: K901012
·
Decision Mar 28, 1990
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
14
Applicant Total
6
Review Days
23
Basic Information
- Device Name
- RADIOGRAPHIC GRID
- K Number
- K901012
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1910
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- INFAB CORP.
- Date Received
- March 5, 1990
- Decision Date
- March 28, 1990
- Product Code
- IXJ
- 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 |
|---|---|---|---|
| IXJ | Grid, Radiographic | FDA class 1 | Radiology |
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Other Clearances by INFAB CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K900970 | RADIATION PROTECTION GLASSES | May 1, 1990 | Substantially Equivalent |
| K900972 | RADIATION PROTECTION GLOVES | May 1, 1990 | Substantially Equivalent |
| K901014 | RADIOGRAPHIC INTENSIFYING SCREEN | Apr 2, 1990 | Substantially Equivalent |
| K901013 | RADIOGRAPHIC FILM CASSETTE | Mar 28, 1990 | Substantially Equivalent |
| K896289 | RADIATION PROTECTION APRON | Dec 14, 1989 | Substantially Equivalent |