510(k) K150893
K150893 is an FDA 510(k) premarket notification submitted by Hamilton Medical AG for the device "IntelliCuff". The FDA issued a decision of Substantially Equivalent on January 29, 2016. The device falls under product code BSK (Cuff, Tracheal Tube, Inflatable), a Class II device regulated under 21 CFR 868.5750. Hamilton Medical AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 2016
- Date Received
- April 2, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cuff, Tracheal Tube, Inflatable
- Device Class
- Class II
- Regulation Number
- 868.5750
- Review Panel
- AN
- Submission Type