CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110
FDA 510(k) clearance K072885 · decided 2008-04-07
Clearance details
- K-number
- K072885
- Device name
- CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110
- Applicant
- Draeger Medical AG & Co. KG
- Decision
- Substantially Equivalent
- Date received
- 2007-10-09
- Decision date
- 2008-04-07
- Days to decision
- 181 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Telford, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Carina Sub-Acute Care Ventilator recall (Z-2248-2023) | Draeger Medical, Inc. | 2023-08-18 |