510(k) K080320
K080320 is an FDA 510(k) premarket notification submitted by Nds Surgical Imaging for the device "PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300". The FDA issued a decision of Substantially Equivalent on Feb 21, 2008. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Nds Surgical Imaging has 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 21, 2008
- Date Received
- Feb 6, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
- 510(k)