510(k) K072926
K072926 is an FDA 510(k) premarket notification submitted by Linde Gas Therapeutics for the device "HELONTIX VENT". The FDA issued a decision of Substantially Equivalent on October 15, 2008. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Linde Gas Therapeutics has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 2008
- Date Received
- October 15, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Continuous, Facility Use
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type