MX960 REUSABLE PRESSURE TRANSDUCER
FDA 510(k) clearance K961404 · decided 1996-06-27
Clearance details
- K-number
- K961404
- Device name
- MX960 REUSABLE PRESSURE TRANSDUCER
- Applicant
- Medex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-04-11
- Decision date
- 1996-06-27
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- DRS
- Device class
- 2
- Regulation number
- 870.2850
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Dublin, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sa recall (Z-1470-2021) | Smiths Medical ASD Inc. | 2021-04-21 |
| Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood sampling recall (Z-1471-2021) | Smiths Medical ASD Inc. | 2021-04-21 |
| LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring. recall (Z-1473-2021) | Smiths Medical ASD Inc. | 2021-04-21 |
| Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks an recall (Z-1474-2021) | Smiths Medical ASD Inc. | 2021-04-21 |
| Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR recall (Z-1477-2021) | Smiths Medical ASD Inc. | 2021-04-21 |