The following data is part of a premarket notification filed by Linde Gas Therapeutics with the FDA for Helontix Vent.
| Device ID | K072926 |
| 510k Number | K072926 |
| Device Name: | HELONTIX VENT |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | LINDE GAS THERAPEUTICS AGA AB Se-181 81lidingo, SE |
| Contact | Ann-cathrin Jareman |
| Correspondent | Ann-cathrin Jareman LINDE GAS THERAPEUTICS AGA AB Se-181 81lidingo, SE |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-15 |
| Decision Date | 2008-10-15 |
| Summary: | summary |