510(k) K953483
K953483 is an FDA 510(k) premarket notification submitted by Smiths Industries Medical Systems, Inc. for the device "SIMS BLUE LINE ENDOBRONCHIAL TUBE". The FDA issued a decision of Substantially Equivalent on October 24, 1995. 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. Smiths Industries Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 24, 1995
- Date Received
- July 25, 1995
- 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