510(k) K133434
K133434 is an FDA 510(k) premarket notification submitted by Dornier Medtech America, Inc. for the device "GENESIS II". The FDA issued a decision of Substantially Equivalent on November 26, 2014. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Dornier Medtech America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 26, 2014
- Date Received
- November 8, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Fluoroscopic, Image-Intensified
- Device Class
- Class II
- Regulation Number
- 892.1650
- Review Panel
- RA
- Submission Type