Infinity M300
FDA 510(k) clearance K200859 · decided 2020-08-28
Clearance details
- K-number
- K200859
- Device name
- Infinity M300
- Applicant
- Draeger Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-04-01
- Decision date
- 2020-08-28
- Days to decision
- 149 days
- Clearance type
- Traditional
- 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 M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on recall (Z-1472-2023) | Draeger Medical Systems, Inc. | 2023-04-27 |