VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310— 510(k) K092029
Substantially EquivalentDraeger Medical AG & Co. KG
FDA 510(k) clearance K092029 for VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310, Substantially Equivalent on 2010-08-06. Applicant: Draeger Medical AG & Co. KG. Device class: 2.
Clearance details
- Applicant
- Draeger Medical AG & Co. KG
- Product code
- Code BYE
- Device class
- Class 2
- Regulation
- 21 CFR 868.5965
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Telford, PA, US
Recent devices under product code BYE
view allMore clearances from Draeger Medical AG & Co. KG
view allAdverse events under product code BYE
product code BYE- Death
- 5
- Total
- 5
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.