INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL
FDA 510(k) clearance K070566 · decided 2007-06-04
Clearance details
- K-number
- K070566
- Device name
- INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL
- Applicant
- Draeger Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-02-28
- Decision date
- 2007-06-04
- Days to decision
- 96 days
- Clearance type
- Special
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors are used to monitor, phy recall (Z-0281-2012) | Draeger Medical, Inc. | 2011-11-23 |
| Infinity Delta Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monitor us recall (Z-3047-2011) | Draeger Medical Systems, Inc. | 2011-08-22 |
| Infinity Gamma X XL Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monit recall (Z-3048-2011) | Draeger Medical Systems, Inc. | 2011-08-22 |
| Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of recall (Z-2283-2010) | Draeger Medical Systems, Inc. | 2010-08-26 |
| Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of recall (Z-2284-2010) | Draeger Medical Systems, Inc. | 2010-08-26 |
| Delta/Delta XL Monitors with Omega S Package recall (Z-0582-2010) | Draeger Medical, Inc. | 2009-12-29 |