HYBERNITE RAINOUT CONTROL SYSTEM— 510(k) K100104
Substantially EquivalentPlastiflex Group NV
FDA 510(k) clearance K100104 for HYBERNITE RAINOUT CONTROL SYSTEM, Substantially Equivalent on 2010-04-14. Applicant: Plastiflex Group NV. Device class: 2.
Clearance details
- Applicant
- Plastiflex Group NV
- 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
- Claremont, NH, US
Recent devices under product code BZE
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- K241268 — Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)
- K234032 — Hudson RCI Dri-Tech Breathing Circuits +6 more
More clearances from Plastiflex Group NV
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.