510(k) K142930
K142930 is an FDA 510(k) premarket notification submitted by Jpi Healthcare Co, Ltd. for the device "Exam Vue DR". The FDA issued a decision of Substantially Equivalent on April 17, 2015. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Jpi Healthcare Co, Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2015
- Date Received
- October 9, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type