510(k) K161605
K161605 is an FDA 510(k) premarket notification submitted by Aqueduct Critical Care, Inc. for the device "Smart External Drain (SED) System". The FDA issued a decision of Substantially Equivalent on Oct 27, 2016. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Aqueduct Critical Care, Inc. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 27, 2016
- Date Received
- Jun 10, 2016
- 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
- 510(k)