CARDIOSERVER
FDA 510(k) clearance K052883 · decided 2005-11-01
Clearance details
- K-number
- K052883
- Device name
- CARDIOSERVER
- Applicant
- Datrix
- Decision
- Substantially Equivalent
- Date received
- 2005-10-13
- Decision date
- 2005-11-01
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Escondido, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) recall (Z-2647-2023) | Baxter Healthcare Corporation | 2023-09-28 |