FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ISOSEED PD-103
K Number: K993552
·
Decision Mar 31, 2000
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
148
Applicant Total
1
Review Days
163
Basic Information
- Device Name
- ISOSEED PD-103
- K Number
- K993552
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5730
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BEBIG ISOTOPENTECHNIK GMBH
- Date Received
- October 20, 1999
- Decision Date
- March 31, 2000
- Product Code
- KXK
- 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 |
|---|---|---|---|
| KXK | Source, Brachytherapy, Radionuclide | FDA class 2 | Radiology |
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