Disposable Double Lumen Endobronchial Tube
Shenzhen Insighters Medical Technology Co., Ltd. · Anesthesiology
Open FDA's page for this record- Third party flag
- N
- City
- Shenzhen
- Advisory committee description
- Anesthesiology
- Address 1
- The 13th Floor Of Hengtemei Bldg., Ganli Rd. #3
- Statement or summary
- Summary
- Product code
- CBI
- Zip code
- 518000
- Applicant
- Shenzhen Insighters Medical Technology Co., Ltd.
- Decision date
- 2024-05-13
- Decision code
- SESE
- Country code
- CN
- Device name
- Disposable Double Lumen Endobronchial Tube
- Advisory committee
- AN
- Contact
- Bonnie Fang
- K number
- K232529
- Date received
- 2023-08-21
- Review advisory committee
- AN
- Postal code
- 518000
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- Medical specialty description
- Anesthesiology
- Regulation number
- 868.5740
- Device class
- 2
- Registration number
- 3010131137, 3003898360, 2025816, 3018094310, 3007134520, 1820334, 3004040397, 3013023209, 9610691, 3014766734, 3004748541, 3007797756, 8040412, 9681384, 2032112, 3014656749, 1314417, 3006425876, 3006984712, 1423662, 3005609751, 3009171251, 3004111573, 3011137372, 3009093866, 3006017180, 9617604, 3000308637, 3010220595, 2936999, 3012050423, 3010400865, 3004784537, 3013528571, 1000563940, 2011171
- FEI number
- 3010131137, 3003898360, 2025816, 3018094310, 3002558692, 3002807626, 3007134520, 1820334, 3004040397, 3013023209, 3014766734, 3004748541, 3007797756, 3000215273, 3006759904, 1314417, 3014656749, 3006425876, 3006984712, 3005609751, 3004111573, 3009271244, 3009093866, 3006017180, 3000308637, 3010220595, 2936999, 3012050423, 3010400865, 3004784537, 3013528571, 3003076831, 1000563940, 3002806359, 3005747797, 2011171