510(k) K100468
K100468 is an FDA 510(k) premarket notification submitted by Carl Zeiss Surgical GmbH for the device "ZEISS INFRARED 800 WITH FLOW 800 OPTION". The FDA issued a decision of Substantially Equivalent on March 3, 2010. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Carl Zeiss Surgical GmbH has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 3, 2010
- Date Received
- February 18, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, X-Ray, Angiographic
- Device Class
- Class II
- Regulation Number
- 892.1600
- Review Panel
- RA
- Submission Type