510(k) K200968
K200968 is an FDA 510(k) premarket notification submitted by Insung Medical Co., Ltd. for the device "ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R". The FDA issued a decision of Substantially Equivalent on December 28, 2020. 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
- December 28, 2020
- Date Received
- April 10, 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