FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STAR
K Number: K801917
·
Decision Sep 16, 1980
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
16
Applicant Total
254
Review Days
36
Basic Information
- Device Name
- STAR
- K Number
- K801917
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1310
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- GENERAL ELECTRIC CO.
- Date Received
- August 11, 1980
- Decision Date
- September 16, 1980
- Product Code
- JWM
- 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 |
|---|---|---|---|
| JWM | System, Tomographic, Nuclear | FDA class 2 | Radiology |
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