510(k) K112210
K112210 is an FDA 510(k) premarket notification submitted by Medical Intelligence Medizintechnik GmbH for the device "FRAXION". The FDA issued a decision of Substantially Equivalent on November 22, 2011. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Medical Intelligence Medizintechnik GmbH has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2011
- Date Received
- August 1, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accelerator, Linear, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type