SURETEMP PLUS
FDA 510(k) clearance K030580 · decided 2003-05-06
Clearance details
- K-number
- K030580
- Device name
- SURETEMP PLUS
- Applicant
- Welch Allyn, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-02-24
- Decision date
- 2003-05-06
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Pr recall (Z-0233-2026) | Baxter Healthcare Corporation | 2025-10-23 |