FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IKOENGELO, VERSION 2
K Number: K083591
·
Decision Dec 29, 2008
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
69
Applicant Total
2
Review Days
25
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Basic Information
- Device Name
- IKOENGELO, VERSION 2
- K Number
- K083591
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5840
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ikoetech, LLC
- Date Received
- December 4, 2008
- Decision Date
- December 29, 2008
- Product Code
- KPQ
- 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 |
|---|---|---|---|
| KPQ | System, Simulation, Radiation Therapy | FDA class 2 | Radiology |
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Other Clearances by Ikoetech, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K061006 | IKOENGELO | Jun 5, 2006 | Substantially Equivalent |