510(k) K123699
K123699 is an FDA 510(k) premarket notification submitted by Andreas Fahl Medizintechnik-Vertrieb GmbH for the device "FAHL TRACHEOSTOMY TUBES (MULTIPLE)". The FDA issued a decision of Substantially Equivalent on Aug 12, 2013. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 12, 2013
- Date Received
- Dec 3, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube Tracheostomy And Tube Cuff
- Device Class
- Class II
- Regulation Number
- 868.5800
- Review Panel
- AN
- Submission Type