510(k) K844835
K844835 is an FDA 510(k) premarket notification submitted by Nuclear Data, Inc. for the device "ND2100 SPINE SCANNER". The FDA issued a decision of Substantially Equivalent on April 18, 1985. The device falls under product code KGI (Densitometer, Bone), a Class II device regulated under 21 CFR 892.1170. Nuclear Data, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 1985
- Date Received
- December 12, 1984
- 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