VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)— 510(k) K222822
Substantially EquivalentDraegerwerk AG & CO Kgaa
FDA 510(k) clearance K222822 for VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608), Substantially Equivalent on 2023-06-14. Applicant: Draegerwerk AG & CO Kgaa. Device class: 2.
Clearance details
- Applicant
- Draegerwerk AG & CO Kgaa
- Product code
- Code BZE
- Device class
- Class 2
- Regulation
- 21 CFR 868.5270
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Luebeck, DE
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More clearances from Draegerwerk AG & CO Kgaa
view allAdverse events under product code BZE
product code BZE- Death
- 4
- Malfunction
- 910
- Other
- 1
- Total
- 915
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.