TEMPERATURE CONTROL & MONITOR
FDA 510(k) clearance K841402 · decided 1984-06-11
Clearance details
- K-number
- K841402
- Device name
- TEMPERATURE CONTROL & MONITOR
- Applicant
- Sams, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-04-03
- Decision date
- 1984-06-11
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- DWC
- Device class
- 2
- Regulation number
- 870.4250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring pat recall (Z-1417-2018) | Terumo Cardiovascular Systems Corporation | 2018-04-18 |
| Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature recall (Z-2208-2016) | Terumo Cardiovascular Systems Corporation | 2016-07-14 |