510(k) K201026
K201026 is an FDA 510(k) premarket notification submitted by Hytek Medical, Inc. for the device "sOLVe Tube". The FDA issued a decision of Substantially Equivalent on August 10, 2021. The device falls under product code CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5740.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 2021
- Date Received
- April 20, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- Device Class
- Class II
- Regulation Number
- 868.5740
- Review Panel
- AN
- Submission Type