510(k) K062104
K062104 is an FDA 510(k) premarket notification submitted by Engineered Medical Systems, Inc. for the device "TALKING TRACH". The FDA issued a decision of Substantially Equivalent on April 20, 2007. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Engineered Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 2007
- Date Received
- July 24, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Tracheostomy (W/Wo Connector)
- Device Class
- Class II
- Regulation Number
- 868.5800
- Review Panel
- AN
- Submission Type