AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)— 510(k) K181649
Substantially EquivalentTrudell Medical International
FDA 510(k) clearance K181649 for AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC), Substantially Equivalent on 2019-01-11. Applicant: Trudell Medical International. Device class: 2.
Clearance details
- Applicant
- Trudell Medical International
- Product code
- Code NVP
- Device class
- Class 2
- Regulation
- 21 CFR 868.5630
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- London, CA
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More clearances from Trudell Medical International
view allAdverse events under product code NVP
product code NVP- Other
- 1
- Total
- 1
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 K181649
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181649.
Data sourced from openFDA. This site is unofficial and independent of the FDA.