510(k) K901854
K901854 is an FDA 510(k) premarket notification submitted by Amersham Corp. for the device "GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412)". The FDA issued a decision of Substantially Equivalent on July 9, 1990. The device falls under product code KGI (Densitometer, Bone), a Class II device regulated under 21 CFR 892.1170. Amersham Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 1990
- Date Received
- April 24, 1990
- 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