INFINITY GAMMA / GAMMAXL, INFINITY VISTA
FDA 510(k) clearance K053484 · decided 2006-02-22
Clearance details
- K-number
- K053484
- Device name
- INFINITY GAMMA / GAMMAXL, INFINITY VISTA
- Applicant
- Draeger Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-12-15
- Decision date
- 2006-02-22
- Days to decision
- 69 days
- Clearance type
- Special
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Danvers, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Infinity Docking Station (IDS) Gamma/Gamma XL and Infinity Vista Series patient Monitors. recall (Z-0302-2007) | Draeger Medical, Inc. | 2006-12-19 |