HELONTIX VENT
FDA 510(k) clearance K072926 · decided 2008-10-15
Clearance details
- K-number
- K072926
- Device name
- HELONTIX VENT
- Applicant
- Linde Gas Therapeutics
- Decision
- Substantially Equivalent
- Date received
- 2007-10-15
- Decision date
- 2008-10-15
- Days to decision
- 366 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Se-181 81lidingo, SE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Linde Gas Therapeutics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.