FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
EXOMIO, MODEL 2.0 SP1
K Number: K032550
·
Decision Sep 25, 2003
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
69
Applicant Total
11
Review Days
38
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Basic Information
- Device Name
- EXOMIO, MODEL 2.0 SP1
- K Number
- K032550
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5840
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medcom GmbH
- Date Received
- August 18, 2003
- Decision Date
- September 25, 2003
- 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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