Bellavista— 510(k) K183364
Substantially EquivalentImtmedical AG
FDA 510(k) clearance K183364 for Bellavista, Substantially Equivalent on 2019-09-13. Applicant: Imtmedical AG. Device class: 2.
Clearance details
- Applicant
- Imtmedical AG
- 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
- Buchs Sg, CH
Recent devices under product code CBK
view allMore clearances from Imtmedical AG
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 K183364
K-number listed on FDA's recall record- Z-1966-2023 — bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
- Z-1967-2023 — bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
- Z-0622-2022 — bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally, infant and neonatal patients.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183364.
Data sourced from openFDA. This site is unofficial and independent of the FDA.