510(k) K151274
K151274 is an FDA 510(k) premarket notification submitted by Good Doctors Co., Ltd. for the device "Dr's Finder". The FDA issued a decision of Substantially Equivalent on February 4, 2016. The device falls under product code LQY (Locator, Root Apex), a Class U device. Good Doctors Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 2016
- Date Received
- May 13, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Locator, Root Apex
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type