FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
1.5` FOCAL SPOT RESOLUTION PATTERN
K Number: K810254
·
Decision Feb 19, 1981
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
4
Applicant Total
4
Review Days
20
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Basic Information
- Device Name
- 1.5` FOCAL SPOT RESOLUTION PATTERN
- K Number
- K810254
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1940
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Machlett Laboratories, Inc.
- Date Received
- January 30, 1981
- Decision Date
- February 19, 1981
- Product Code
- IXF
- 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 |
|---|---|---|---|
| IXF | Test-Pattern, Radiographic | FDA class 1 | Radiology |
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