510(k) K894337
K894337 is an FDA 510(k) premarket notification submitted by Vitaid, Ltd. for the device "UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM". The FDA issued a decision of Substantially Equivalent on September 29, 1989. 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. Vitaid, Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 1989
- Date Received
- July 14, 1989
- 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