510(k) K180621
K180621 is an FDA 510(k) premarket notification submitted by Sonavex, Inc. for the device "EchoMark, EchoMark LP". The FDA issued a decision of Substantially Equivalent on Jun 6, 2018. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Sonavex, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 6, 2018
- Date Received
- Mar 9, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Marker, Radiographic, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type