Bellavista
FDA 510(k) clearance K183364 · decided 2019-09-13
Clearance details
- K-number
- K183364
- Device name
- Bellavista
- Applicant
- Imtmedical AG
- Decision
- Substantially Equivalent
- Date received
- 2018-12-04
- Decision date
- 2019-09-13
- Days to decision
- 283 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Buchs Sg, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator recall (Z-1966-2023) | Vyaire Medical | 2023-06-15 |
| bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator recall (Z-1967-2023) | Vyaire Medical | 2023-06-15 |
| bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100. recall (Z-0622-2022) | Vyaire Medical | 2022-02-16 |