Vigilant Software Suite – Vigilant Master Med
FDA 510(k) clearance K210075 · decided 2022-03-01
Clearance details
- K-number
- K210075
- Device name
- Vigilant Software Suite – Vigilant Master Med
- Applicant
- Fresenius Kabi AG
- Decision
- Substantially Equivalent
- Date received
- 2021-01-12
- Decision date
- 2022-03-01
- Days to decision
- 413 days
- Clearance type
- Traditional
- Product code
- PHC
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bad Homburg, DE
- Third-party review
- No
- Expedited review
- No
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| Dose IQ Safety Software (K211124) | Baxter Healthcare Corporation | 2022-08-30 |
| BD Intelliport System (K182092) | Becton, Dickinson and Company | 2019-04-30 |
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Recalls involving this device
No recalls on record reference this clearance.