CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS— 510(k) K081743
Substantially EquivalentDraeger Medical AG & Co. KG
FDA 510(k) clearance K081743 for CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS, Substantially Equivalent on 2008-09-22. Applicant: Draeger Medical AG & Co. KG. Device class: 2.
Clearance details
- Applicant
- Draeger Medical AG & Co. KG
- Product code
- Code CBK
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Luebeck, DE
Recent devices under product code CBK
view allMore clearances from Draeger Medical AG & Co. KG
view allAdverse events under product code CBK
product code CBK- Death
- 736
- Injury
- 3,628
- Malfunction
- 98,786
- Other
- 4
- Total
- 103,154
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 →
Recalls naming K081743
K-number listed on FDA's recall record- Z-1137-2023 — NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)
- Z-1138-2023 — NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081743.
Data sourced from openFDA. This site is unofficial and independent of the FDA.