WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES
FDA 510(k) clearance K101680 · decided 2010-07-09
Clearance details
- K-number
- K101680
- Device name
- WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES
- Applicant
- Welch Allyn, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-06-15
- Decision date
- 2010-07-09
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Skaneateles Falls, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the fo recall (Z-1509-2024) | Baxter Healthcare Corporation | 2024-04-10 |