510(k) K172035
K172035 is an FDA 510(k) premarket notification submitted by Btg International, Inc. for the device "EKOS ultrasound EVD Device, EVD Control Unit". The FDA issued a decision of Substantially Equivalent on Mar 24, 2018. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Btg International, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 24, 2018
- Date Received
- Jul 5, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shunt, Central Nervous System And Components
- Device Class
- Class II
- Regulation Number
- 882.5550
- Review Panel
- NE
- Submission Type