FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HIGH TRANSMISSION CELLULAR (HTC) GRIDS 18X24 CM & 24X30 CM SIZES
K Number: K954294
·
Decision Feb 2, 1996
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
14
Applicant Total
1
Review Days
141
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Basic Information
- Device Name
- HIGH TRANSMISSION CELLULAR (HTC) GRIDS 18X24 CM & 24X30 CM SIZES
- K Number
- K954294
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1910
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Thermotrex Corp.
- Date Received
- September 14, 1995
- Decision Date
- February 2, 1996
- 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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