FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CRISA
K Number: K833847
·
Decision Dec 12, 1983
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
39
Applicant Total
3
Review Days
88
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Basic Information
- Device Name
- CRISA
- K Number
- K833847
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1760
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- X-Ray Tube Corp.
- Date Received
- September 15, 1983
- Decision Date
- December 12, 1983
- Product Code
- ITY
- 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 |
|---|---|---|---|
| ITY | Assembly, Tube Housing, X-Ray, Diagnostic | FDA class 1 | Radiology |
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