510(k) K021527
K021527 is an FDA 510(k) premarket notification submitted by Sectra-Imtec AB for the device "SECTRA OSTEOPOROSIS PACKAGE". The FDA issued a decision of Substantially Equivalent on June 7, 2002. The device falls under product code KGI (Densitometer, Bone), a Class II device regulated under 21 CFR 892.1170. Sectra-Imtec AB has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 7, 2002
- Date Received
- May 10, 2002
- Clearance Type
- Special
- 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