510(k) K080612
K080612 is an FDA 510(k) premarket notification submitted by Leica Microsystems (Schweiz) AG for the device "LEICA FL800". The FDA issued a decision of Substantially Equivalent on May 9, 2008. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Leica Microsystems (Schweiz) AG has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 2008
- Date Received
- March 4, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Angiographic
- Device Class
- Class II
- Regulation Number
- 892.1600
- Review Panel
- RA
- Submission Type