FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
EXOMIO, MODEL 1.1
K Number: K022219
·
Decision Oct 7, 2002
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
69
Applicant Total
11
Review Days
90
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Basic Information
- Device Name
- EXOMIO, MODEL 1.1
- K Number
- K022219
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5840
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medcom GmbH
- Date Received
- July 9, 2002
- Decision Date
- October 7, 2002
- 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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