FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BC/WT/PF
K Number: K930249
·
Decision Apr 27, 1993
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
20
Applicant Total
3
Review Days
98
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Basic Information
- Device Name
- BC/WT/PF
- K Number
- K930249
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1880
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tingle X-Ray Products, Inc.
- Date Received
- January 19, 1993
- Decision Date
- April 27, 1993
- Product Code
- IXY
- 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 |
|---|---|---|---|
| IXY | Holder, Radiographic Cassette, Wall-Mounted | FDA class 1 | Radiology |
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