510(k) K011611
K011611 is an FDA 510(k) premarket notification submitted by Danish Diagnostic Development A/S for the device "CARDIOCAM MODEL 9CSY0799". The FDA issued a decision of Substantially Equivalent on June 8, 2001. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Danish Diagnostic Development A/S has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 2001
- Date Received
- May 25, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Tomography, Computed, Emission
- Device Class
- Class II
- Regulation Number
- 892.1200
- Review Panel
- RA
- Submission Type