FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
L/U ARM-VASCULAR
K Number: K781571
·
Decision Nov 27, 1978
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
39
Applicant Total
254
Review Days
74
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Basic Information
- Device Name
- L/U ARM-VASCULAR
- K Number
- K781571
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1770
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- General Electric Co.
- Date Received
- September 14, 1978
- Decision Date
- November 27, 1978
- Product Code
- IYB
- 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 |
|---|---|---|---|
| IYB | Tube Mount, X-Ray, Diagnostic | FDA class 1 | Radiology |
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