FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTISOURCE, MODEL 1032P
K Number: K040766
·
Decision Jul 22, 2004
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
150
Applicant Total
2
Review Days
119
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Basic Information
- Device Name
- OPTISOURCE, MODEL 1032P
- K Number
- K040766
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5730
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- International Brachytherapy S.A.
- Date Received
- March 25, 2004
- Decision Date
- July 22, 2004
- 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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Other Clearances by International Brachytherapy S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K973328 | INTERSOURCE | Dec 10, 1998 | Substantially Equivalent |