510(k) K983314
K983314 is an FDA 510(k) premarket notification submitted by Nycomed Amersham Imaging for the device "PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on February 19, 1999. The device falls under product code IZQ (Injector, Contrast Medium, Automatic), a Class II device regulated under 21 CFR 870.1650.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 1999
- Date Received
- September 21, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Injector, Contrast Medium, Automatic
- Device Class
- Class II
- Regulation Number
- 870.1650
- Review Panel
- HO
- Submission Type