510(k) K033550
K033550 is an FDA 510(k) premarket notification submitted by Demetech AB for the device "DXL CALSCAN". The FDA issued a decision of Substantially Equivalent on May 5, 2004. The device falls under product code KGI (Densitometer, Bone), a Class II device regulated under 21 CFR 892.1170. Demetech AB has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 2004
- Date Received
- November 12, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Densitometer, Bone
- Device Class
- Class II
- Regulation Number
- 892.1170
- Review Panel
- RA
- Submission Type