FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODUMED MUGE
K Number: K780369
·
Decision Mar 14, 1978
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
16
Applicant Total
475
Review Days
7
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Basic Information
- Device Name
- MODUMED MUGE
- K Number
- K780369
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1310
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Medtronic Vascular
- Date Received
- March 7, 1978
- Decision Date
- March 14, 1978
- 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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