510(k) K171867

Dr’s Finder NEO by Good Doctors Co., Ltd. — Product Code LQY

K171867 is an FDA 510(k) premarket notification submitted by Good Doctors Co., Ltd. for the device "Dr’s Finder NEO". The FDA issued a decision of Substantially Equivalent on March 30, 2018. 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
March 30, 2018
Date Received
June 22, 2017
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