POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR
FDA 510(k) clearance K031124 · decided 2003-12-04
Clearance details
- K-number
- K031124
- Device name
- POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR
- Applicant
- Datex-Ohmeda, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-08
- Decision date
- 2003-12-04
- Days to decision
- 240 days
- Clearance type
- Traditional
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Issaquah, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The Ultraview SL 91517 Capnography module is a mainstream and sidestream gas analyzer desi recall (Z-2573-2011) | Spacelabs Healthcare, Llc | 2011-06-20 |
| Ultraview SL Capnography Module, Model 91517 A mainstream and sidestream gas analyzer desi recall (Z-0517-06) | Spacelabs Medical Incorporated | 2006-02-16 |