510(k) K140214
K140214 is an FDA 510(k) premarket notification submitted by Jvckenwood Corporation for the device "30.0 INCH COLOR LCD MONITOR CCL650I2 (CL30650, MD302C6)". The FDA issued a decision of Substantially Equivalent on February 19, 2014. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Jvckenwood Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 2014
- Date Received
- January 28, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type