510(k) K210789
K210789 is an FDA 510(k) premarket notification submitted by Meta Systems Co., Ltd. for the device "EQ-PEX". The FDA issued a decision of Substantially Equivalent on October 20, 2021. The device falls under product code LQY (Locator, Root Apex), a Class U device. Meta Systems Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 2021
- Date Received
- March 16, 2021
- 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