510(k) K080742
K080742 is an FDA 510(k) premarket notification submitted by Medcom GmbH for the device "VERISUITE 1.6, VERISUITE-PARTICLE 1.6". The FDA issued a decision of Substantially Equivalent on May 9, 2008. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Medcom GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 2008
- Date Received
- March 17, 2008
- 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