WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE)
FDA 510(k) clearance K070060 · decided 2007-12-18
Clearance details
- K-number
- K070060
- Device name
- WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE)
- Applicant
- Welch Allyn, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-01-05
- Decision date
- 2007-12-18
- Days to decision
- 347 days
- Clearance type
- Traditional
- Product code
- DXQ
- Device class
- 2
- Regulation number
- 870.1120
- 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 |
|---|---|---|
| Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece R recall (Z-1568-2025) | Baxter Healthcare Corporation | 2025-04-15 |