FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP)
K Number: K983918
·
Decision Mar 12, 1999
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
50
Applicant Total
1
Review Days
128
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Basic Information
- Device Name
- RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP)
- K Number
- K983918
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1850
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mastek, Inc.
- Date Received
- November 4, 1998
- Decision Date
- March 12, 1999
- Product Code
- IXA
- 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 |
|---|---|---|---|
| IXA | Cassette, Radiographic Film | FDA class 2 | Radiology |
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