RAPIDPoint 500e Blood Gas System
FDA 510(k) clearance K192240 · decided 2020-03-27
Clearance details
- K-number
- K192240
- Device name
- RAPIDPoint 500e Blood Gas System
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-08-19
- Decision date
- 2020-03-27
- Days to decision
- 221 days
- Clearance type
- Special
- Product code
- CHL
- Device class
- 2
- Regulation number
- 862.1120
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Norowood, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 1 recall (Z-2214-2024) | Siemens Healthcare Diagnostics Inc | 2024-06-26 |
| RAPIDPOINT 500e Blood Gas System recall (Z-0422-2024) | Siemens Healthcare Diagnostics Inc | 2023-12-01 |
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