FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇭 Switzerland
DI2000/HS-45-150 X-RAY TUBE INSERT
K Number: K910842
·
Decision Mar 6, 1991
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
39
Applicant Total
5
Review Days
7
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Basic Information
- Device Name
- DI2000/HS-45-150 X-RAY TUBE INSERT
- K Number
- K910842
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1760
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Comet Ltd. C/O Radiology Resources, Inc.
- Date Received
- February 27, 1991
- Decision Date
- March 6, 1991
- 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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