FABIUS MRI
FDA 510(k) clearance K072884 · decided 2008-07-30
Clearance details
- K-number
- K072884
- Device name
- FABIUS MRI
- Applicant
- Draeger Medical AG & Co. KG
- Decision
- Substantially Equivalent
- Date received
- 2007-10-09
- Decision date
- 2008-07-30
- Days to decision
- 295 days
- Clearance type
- Traditional
- Product code
- BSZ
- Device class
- 2
- Regulation number
- 868.5160
- 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 |
|---|---|---|
| Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhala recall (Z-1481-2018) | Draeger Medical, Inc. | 2018-05-08 |
| Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in M recall (Z-2271-2015) | Draeger Medical, Inc. | 2015-07-27 |