FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
JPI X-RAY GRID
K Number: K945327
·
Decision Jan 20, 1995
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
14
Applicant Total
3
Review Days
80
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Basic Information
- Device Name
- JPI X-RAY GRID
- K Number
- K945327
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1910
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Jpi America, Inc.
- Date Received
- November 1, 1994
- Decision Date
- January 20, 1995
- 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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